Articles

Drug

Real-World Evidence in FDA Prescribing Information Labeling

Which FDA-approved drugs include real-world data in their labeling, and what methodological standards determine whether RWD/RWE qualifies.

Drug

Patient-Reported Outcomes in CDER Prescribing Information

How CDER has incorporated PRO instruments into approved prescribing information from 2021–2026, by therapeutic area, instrument, and labeling section.

Drug

Ozempic (Semaglutide) Prescribing Information Changes Since 2022

All FDA-approved labeling supplements for Ozempic (semaglutide, NDA 209637) since 2022, covering new indications, safety updates, and pen/packaging changes.

Drug

Primary Endpoints for Phase 3 Huntington's Disease Trials

Phase 3 primary endpoints accepted by FDA and EMA for Huntington's disease trials, covering approved chorea therapies and registered disease-modifying programs.

Drug

Phase 2 Endpoints in Recurrent/Metastatic HNSCC Trials

Primary endpoints used in Phase 2 R/M HNSCC trials and their regulatory acceptability for accelerated or traditional approval under FDA and EMA frameworks.

Drug

FDA Feedback in Pre-IND Type B Meetings for Solid Tumors

FDA feedback from pre-IND Type B meetings for solid tumor programs, covering nonclinical adequacy, dose selection, CMC, trial design, and biomarkers.

Drug

U.S. Representation in Multiregional Trials: FDA Approval Trends

Whether FDA is hardening US enrollment requirements in oncology MRCTs—via 21 CFR 312.120, the Sept 2024 draft MRCT guidance, ICH E17, and CRL precedents.

Drug

COA and PRO Instruments in FDA GLP-1 Obesity and CV Programs

COA and PRO instruments found in FDA labeling and clinical reviews for GLP-1 obesity and cardiovascular outcome programs, with regulatory context.

Drug

FDA Labeling and CMC Issues on Daptomycin Products, 2021–2026

Key FDA labeling and CMC deficiencies raised on daptomycin NDAs and ANDAs from 2021 to 2026, covering impurities, sterility, stability, and labeling.

Drug

FDA-Approved Second-Line Therapies for Hepatocellular Carcinoma

FDA-approved second-line therapies for advanced HCC after sorafenib: regorafenib, cabozantinib, ramucirumab, pembrolizumab, and nivolumab, with indications.

Drug

ICH E6(R3) vs. E6(R2): Changes to Sponsor Responsibilities

ICH E6(R2) vs. E6(R3) sponsor obligations: quality management, risk-proportionate monitoring, digital data governance, and service-provider oversight.

Drug

US ORR-Based Oncology Approvals, DoR Under 6 Months: 2021–2026

FDA oncology approvals (July 2021–2026) where ORR was the primary efficacy basis and median duration of response in pivotal population was under 6 months.

Drug

Phase 1, 2, and 3 Clinical Trials: FDA Definitions to Advance

FDA's definitions of Phase 1, 2, and 3 trials and the procedural and substantive requirements sponsors must meet to advance between them.

Drug

FDA 483s, Warning Letters, and Import Alerts: How They Escalate

Definitions, legal distinctions, and real escalation pathways among FDA's three core enforcement instruments: Form 483, warning letter, and import alert.

Drug

FDA Complete Response Letter: What It Is and What Happens Next

What an FDA Complete Response Letter is, what it contains, and the regulatory steps and timelines a sponsor must navigate after receiving one.

Drug

GMP Basics and When FDA Expects Compliance: Enforcement Lessons

What GMP requires, when FDA enforcement says it applies, and what early-stage manufacturers have actually been cited for.

Drug

IND Applications: FDA Expectations and Clinical Hold Triggers

IND requirements, FDA expectations by phase, and the specific deficiencies that have triggered clinical holds — drawn from the governing regulations.

Drug

NDA, BLA, or ANDA: Choosing the Right Marketing Pathway

Which FDA marketing application — NDA, BLA, or ANDA — applies to your product, and how the three pathways differ in evidence, exclusivity, and process.

Drug

Orphan Drug Designation: Incentives and FDA Refusal Grounds

Orphan drug designation explained: the US criteria, sponsor benefits including exclusivity, and grounds for FDA denial.

Drug

Fast Track vs Breakthrough Therapy vs RMAT vs Priority Review

How Fast Track, Breakthrough Therapy, RMAT, and Priority Review differ in eligibility, timing, and the specific FDA review mechanics each one unlocks.

Drug

Accelerated Approval: Framework and Failed Confirmatory Trials

How accelerated approval works under FDA statute, and what has happened in practice when confirmatory trials failed to validate the surrogate endpoint.

Drug

Drug Master Files and Letters of Authorization: What FDA Expects

What a Drug Master File is, how suppliers authorize client references, and what FDA guidance requires for DMF content and letters of authorization.

Drug

REMS Programs: Safety Findings That Trigger an FDA Requirement

REMS definition, legal authority under FDAAA, and the safety findings and risk criteria that lead FDA to require one.

Drug

Why FDA Issues Complete Response Letters: Recurring Deficiencies

The deficiency categories FDA cites most often in Complete Response Letters, and the specific findings that recur across NDAs, BLAs, and ANDAs.

Drug

Meeting Pathways: FDA, EMA, MHRA, Health Canada, PMDA, NMPA

A side-by-side comparison of formal regulatory meeting pathways across FDA, EMA, MHRA, Health Canada, PMDA, and NMPA, including types, triggers, and timelines.

Drug

FDA Data-Integrity Failures and 21 CFR Part 11 Spreadsheets

FDA's most-cited data-integrity failures in warning letters and why spreadsheet-based records cannot meet 21 CFR Part 11 requirements.

Drug

Drug Master Files: FDA, EMA, PMDA, Health Canada, TGA Compared

Side-by-side comparison of DMF systems at FDA, EMA, PMDA, Health Canada, and TGA—covering registration, structure, access procedures, and fees.

Drug

Converting a Protocol Into a Master Protocol Under an Active IND

FDA's regulatory framework for converting or restructuring an existing protocol into a master protocol under an active IND.

Drug

Digital Trial Recruitment Ads: FDA, Health Canada, IRB/REB

FDA and Health Canada rules for digital clinical-trial recruitment ads: permissible content, IRB/REB review, and tracking pixel considerations.

Drug

FDA Drug Repurposing to a New Indication With Phase 2 Data

How FDA credits prior Phase 2 data in drug repurposing programs, covering 505(b)(2) applications, efficacy supplements, and substantial-evidence standards.

Drug

Minimal Residual Disease (MRD) as an FDA Endpoint or Evidence

Where and how FDA has accepted MRD as a primary endpoint or supportive evidence across hematologic malignancy approvals.

Drug

FDA Boxed Warnings: Evidence Patterns Behind Labeling Action

How FDA justifies boxed warnings by evidence type — trial data, meta-analyses, animal studies, and post-market reports — with product examples.

Drug

Breakthrough Therapy Designation Since 2020: What It Changes

How Breakthrough Therapy Designation has been used in recent approvals, how it interacts with other expedited pathways, and what it changes in review.

Drug

FDA 483 Observations by Frequency and Quality-System Subsystem

FDA 483 observations ranked by frequency and mapped to CGMP and QSIT quality-system subsystems, with the CFR provisions most often cited.

Drug

FDA and ICH on Fish Embryo Assays for Embryo-Fetal Studies

FDA and ICH regulatory standing of fish embryo assays as alternatives or adjuncts to standard mammalian embryo-fetal development studies.

Drug

FDA Nonclinical Expectations for Veterinary or Ex-US Compounds

FDA nonclinical requirements when a veterinary or ex-US approved compound enters US human development, including gap analysis and bridging strategy.

Drug

FDA Rules for Oral Liquid Dosing Devices and Dosing Errors

FDA's oral liquid dosing-device requirements explained alongside the pediatric dosing errors and labeling problems that shaped them.

Drug

ANDA Guidance and Approvals for First-Time Generics Sponsors

Key FDA requirements and approval patterns for bioequivalence, CMC, patent certification, and submission mechanics in a first ANDA filing.

Drug

FDA Peptide Approvals and Guidance: The Regulatory Path

FDA peptide approvals, generic pathways, and guidance examined to clarify clinical pharmacology and regulatory expectations for peptide developers.

Drug

Effective FDA Briefing Books: What Review Divisions Want

What separates FDA briefing books that drive decisions from those that stall programs — drawn from review division meeting minutes and correspondence.

Drug

ICH E3 Statistical Methods in CSRs and EU CTIS Practice

ICH E3 requirements for the CSR statistical methods section and how EU CTIS sponsors structure it, including Appendix 16.1.9 cross-referencing practice.

Drug

FDA Requirements for First-in-Human Oncology IND Trials

FDA's nonclinical requirements, starting-dose justification, dose-escalation standards, and clinical hold triggers for first-in-human oncology INDs.

Drug

Psychedelic Trial Design: Blinding, Endpoints, and FDA on MDMA

Blinding strategies, comparator arms, and endpoints in real psychedelic trial records, plus FDA's design concerns from the Lykos MDMA review.

Drug

FDA Post-Approval Changes: Annual Report, CBE-30, or PAS

How sponsors classify post-approval manufacturing changes across FDA reporting tiers, with real examples of Agency disagreements on category selection.

Drug

EMA CHMP Qualification of Novel Methodologies and Biomarkers

How the EMA qualifies novel biomarkers, outcome assessments, and models, and what a qualification opinion or letter of support signals to sponsors.

Drug

FDA-Approved Drugs for Obstructive Hypertrophic Cardiomyopathy

FDA-approved oHCM drug therapies, with the pivotal endpoints, trial designs, labeling restrictions, and REMS behind each approval.

Drug

China's NMPA Conditional Approval Pathway for Oncology Products

How China's NMPA applies conditional approval in oncology: eligibility, evidence standards, post-approval commitments, and the products granted it.

Drug

FDA Guidance for Inflammatory Bowel Disease Drug Development

How FDA guidances shape endpoints, trial design, and efficacy standards for ulcerative colitis, Crohn's disease, and pediatric IBD drugs.

Drug

Prodrug Strength in FDA Labeling: Active Moiety vs. Prodrug

How FDA has expressed prodrug strength in labeling — as active-moiety equivalents versus the prodrug itself — and the approved precedents on each side.

Drug

Phase I Transparency Under the EU Clinical Trials Regulation

Which Phase I trial documents CTIS publishes, on what timelines, and how sponsors use deferral and redaction to manage disclosure.

Drug

Recent ANDA Approvals: FDA's Newest Generic Drug Clearances

A structured look at FDA's most recent ANDA approvals — active ingredients, dosage forms, and first-generic milestones.

Drug

Pediatric and Neonatal Drug Trials: FDA Requirements Under PREA and Pediatric Study Plans

How FDA's PREA and BPCA requirements, pediatric study plans, and subpart D ethical protections govern drug trials in children and neonates.

Drug

Starting a First-in-Human Trial: FDA IND, China NMPA, and Australia CTN/CTX Compared

Compares FDA IND, China NMPA, and Australia CTN/CTX requirements for authorizing a first-in-human trial — documentation and timelines side by side.

Drug

Common FDA 483 and Warning-Letter Observations in Aseptic Fill-Finish, Mapped to EU GMP Annex 1

The recurring FDA 483 and warning-letter observations against aseptic fill-finish operations, mapped to their EU GMP Annex 1 counterparts.

Drug

Recent FDA Approvals of Non-Opioid Analgesics: Mechanisms, Indications, and Pivotal Evidence

Recent FDA-approved non-opioid analgesics, their mechanisms of action, approved indications, and the pivotal evidence supporting each.

Drug

cGMP for Radiopharmaceuticals and Radionuclides in Late-Phase Trials: Short Half-Lives and Dosimetry

How FDA cGMP rules govern radiopharmaceutical manufacturing in late-phase trials, including short half-life release testing and dosimetry.

Drug

FDA Drug Approvals Targeting GPCR Mechanisms, 2021 to 2026

GPCR-targeted drugs the FDA approved from 2021 to mid-2026, with receptor targets, receptor classes, and therapeutic areas.

Drug

Population Pharmacokinetics in NDA and BLA Submissions: FDA Expectations and Labeling Impact

FDA's expectations for popPK in NDA and BLA filings, with approved-drug examples where the analysis shaped Specific Populations, dosing, and pediatric labeling.

Drug

FDA Approvals Based on Prespecified Subgroup Results After a Failed Overall Trial

How FDA treats prespecified subgroup wins when the overall pivotal trial fails, drawn from approval precedents and Complete Response Letters.

Drug

How FDA Assesses Drug-Induced Liver Injury: Hy's Law, eDISH, and Liver-Safety Monitoring Expectations

How FDA evaluates DILI risk: Hy's Law criteria, eDISH screening, liver-safety monitoring expectations, and hepatotoxicity findings in CRLs and labeling.

Drug

How FDA Facility Inspection Outcomes Shape NDA and BLA Approvals

How Form 483 observations, OAI classifications, and facility withholds convert into Complete Response Letters and delayed NDA and BLA approvals.

Drug

FDA Pre-Approval Inspections: Timing After NDA/BLA Submission and How Facilities Are Selected

How FDA times pre-approval inspections during NDA/BLA review and the risk factors that determine which manufacturing facilities get inspected.

Drug

GLP-1 Receptor Agonists in Clinical Development: The Emerging Pipeline and Recent FDA and EMA Decisions

Clinical trial records and FDA/EMA decisions mapping the GLP-1 agonist pipeline: approved agents, oral and multi-receptor candidates, and expanding indications.

Combination Product

CDER Injectable Combination Product Deficiencies, 2024–2025

Recurring CDER CMC and device essential-performance deficiency themes from 2024–2025 NDA/BLA reviews of injectable drugs and delivery systems.

Combination Product

FDA ISO 11040 Prefilled-Syringe Testing on Autoinjectors

Whether FDA requires ISO 11040 prefilled-syringe tests on finished autoinjectors, and how ISO 11040/11608 scope boundaries apply to combination products.

Combination Product

CDER Review Questions on Autoinjectors and Prefilled Pens

Device-related CDER deficiencies, information requests from BLA reviews since 2023 for autoinjector and prefilled pen products, excluding human factors/IFU

Combination Product

FDA Information Requests on 21 CFR Part 4 Combination cGMP

FDA information requests to combination-product applicants on 21 CFR Part 4 cGMP, organized by QSR provision with application numbers and product names.

Combination Product

CDER BLA Supplement Type to Extend Autoinjector Shelf Life

Which BLA supplement type CDER requires to extend labeled shelf life for autoinjector or prefilled pen presentations, based on Drugs@FDA records from 2021–2026.

Combination Product

Real-Life Handling Studies for Autoinjectors and Pens, 2020–2026

Real-life patient handling and home-use studies cited in FDA and EMA approval packages for autoinjectors and prefilled pens, 2020–2026.

Combination Product

FDA ISO 11608 Conformance for Prefilled Syringes in NDAs/BLAs

How FDA has applied ISO 11608 standards in NDA/BLA reviews for prefilled syringes and PFS/NSD combination products from 2021 through mid-2026.

Combination Product

Autoinjector and Prefilled Pen Usability Studies in EU CTIS

EU CTIS-registered trials incorporating actual-use or usability assessments for autoinjectors and prefilled pens, covering 23 qualifying protocols.

Combination Product

FDA DMEPA URRA Revision Requirements in BLA/NDA Reviews

CDER and CBER review records from 2021–2026 show URRA revision requests are routine FDA human factors review outcomes, not exceptional occurrences.

Combination Product

FDA Autoinjector Testing Requests With Acceptable Responses

CDER information requests on prefilled autoinjector testing since 2022 where FDA explicitly recorded the applicant's response as acceptable.

Combination Product

Combination Product Types: Four Categories Under 21 CFR 3.2(e)

FDA's four combination product types under 21 CFR 3.2(e), how OCP assigns lead-center jurisdiction, and why classification drives pathway and reporting.

Combination Product

Type II DMF and FDA AMT Designation for Multiple ADC Clients

How ADC linker suppliers use a Type II DMF and FDA AMT designation to confidentially support multiple client applications via one pre-vetted platform.

Combination Product

Autoinjector Use Errors vs. Device Defects: Evidence from MAUDE

MAUDE analysis distinguishing autoinjector use errors from confirmed device defects—needlestick, incomplete dose, premature activation, and wrong-end use.

Combination Product

Drug, Device, Biologic, or Combination Product: FDA Classifies

How FDA statutory definitions, the PMOA standard, and formal designation determine if your product is a drug, device, biologic, or combination product.

Combination Product

Extractables and Leachables in FDA Combination-Product Reviews

FDA's E&L data requests across recent injectable, biologic, and combination-product reviews—what was asked, why, and against what framework.

Combination Product

Delivery-Device Changes to Subcutaneous Combination Products

How FDA has weighed human-factors, use-related risk, and PK bridging evidence for device changes to approved subcutaneous combination products.

Combination Product

Identifying and Justifying Critical Tasks in the Use-Related Risk Analysis for Autoinjectors and Pen Injectors

How FDA expects sponsors to derive, justify, and document critical tasks in the use-related risk analysis for autoinjectors and pen injectors.

Biologic

FDA Review of In-Process Bioburden Limits in BLAs, 2021–2026

FDA microbiology findings on in-process bioburden limits, alert/action levels, hold-time studies, and method suitability across BLAs approved 2021–2026.

Biologic

EMA Nonclinical Toxicity Data for Polyvalent Immunoglobulins

Nonclinical toxicity data EMA accepts for human polyvalent immunoglobulins, with EPAR-based comparisons across Kiovig, Privigen, Hizentra, and HyQvia.

Biologic

FDA Controls for Retroviral/Lentiviral CAR-T Vectors

FDA controls required for BLA approval of retroviral and lentiviral CAR-T therapies: vector design, integration-site testing, and postmarket follow-up.

Biologic

Dupixent (Dupilumab) FDA Labeling Changes, July 2022–2026

All FDA-approved labeling changes for Dupixent (dupilumab, BLA 761055) from July 2022 through July 2026, by supplement and approval date.

Biologic

FDA Preclinical Testing for Large-Molecule Drugs at IND Stage

Nonclinical testing FDA expects before an original IND for a large-molecule biologic, mapped across ICH S6(R1), M3(R2), S7A, and related guidances.

Biologic

Preclinical Toxicity Endpoints for Large-Molecule Drugs (FDA)

Nonclinical toxicity endpoints required for FDA approval of biologics under ICH S6(R1), adapted for species specificity and immunogenicity considerations.

Biologic

Research-Grade Protein to cGMP-Compliant Clinical Product

Transitioning recombinant protein from bench reagent to GMP investigational product: cell bank qualification, quality systems, analytical validation, release.

Biologic

Juvenile Animal Toxicity Study Waivers for Monoclonal Antibodies

How to justify a juvenile animal study waiver for monoclonal antibodies under ICH S6(R1), iPSP requirements, and FDA's 2025 draft nonclinical guidance.

Biologic

FDA Bispecific Antibody Approval vs Monoclonal Antibodies

Key FDA requirements for bispecific antibody approval that go beyond what a conventional monoclonal antibody submission must address.

Biologic

Endotoxin and Product-Contact Buffer Controls in FDA BLAs

FDA expectations for endotoxin limit justification and product-contact buffer controls, drawn from CBER and CDER BLA review memos over the last five years.

Biologic

FDA Cell and Gene Therapy Approvals: The Evidence Behind Them

How recent FDA cell and gene therapy approvals have been supported, by modality, with representative pivotal evidence rather than a complete inventory.

Biologic

CQAs and Analytical Similarity in FDA 351(k) Biosimilars

How FDA evaluates CQA tiering, analytical methods, and similarity findings across approved 351(k) biosimilars, with examples.

Biologic

505(b)(2) Eligibility for Biologics: The Drug-Biologic Boundary and the Deemed-BLA Transition

Whether 505(b)(2) can be used for a biologic, how FDA draws the drug-biologic line for proteins, and what the deemed-BLA transition changed.

Biologic

FDA-Approved RSV Vaccines and Monoclonal Antibodies: Labeled Indications

The six FDA-licensed RSV products — three vaccines and three monoclonal antibodies — with their BLA numbers, approval dates, and labeled populations.

Device

Energy-Based Medical Devices Cleared and Approved, 2023–2026

FDA-cleared and approved energy-based devices from 2023 through mid-2026, organized by modality across 510(k), De Novo, and PMA pathways.

Device

Point-of-Care Diagnostic Device Clinical Trials: Registry Review

Clinical trials of point-of-care diagnostic devices registered across CTIS, EudraCT, MHRA, SNCTP, and jRCT, by device type, indication, and study design.

Device

FDA Acceptance of Out-of-US RWE in De Novo Classifications

De Novo classifications where FDA accepted ex-US real-world evidence, characterized by registry, geography, sample size, and benefit-risk role.

Device

FDA Medical Device Product Codes: Assignment and Responsibility

How FDA three-character device product codes are created and maintained by CDRH, and how to use them for predicate identification and classification strategy.

Device

Sampling Plans and Sample Size for Design V&V Under ISO 13485

FDA guidance and standards for statistically defensible sampling plans in device design verification and validation under ISO 13485:2016 clauses 7.3.6–7.3.7.

Device

FDA PMA and HDE Submission Changes Under QMSR: Draft Guidance

FDA's October 2025 draft guidance on QMS information in PMA and HDE submissions under QMSR, and how it differs from the 2003 predecessor.

Device

Panel-Track PMA Supplements: When FDA Waives Advisory Review

FDA has discretion to waive advisory committee referral for panel-track PMA supplements—the regulatory basis and how that discretion is applied.

Device

MDR Stage 1 Audit Preparation for Reusable Surgical Instruments

MDR requirements—QMS, technical documentation, clinical evaluation, PMS, UDI, reprocessing—for Class Ir reusable surgical instruments before Stage 1 audit.

Device

513(g) Request Content for a Dental Device Without a Predicate

Content required in a 513(g) Request for an early-stage dental device without a clear predicate, versus Q-Submissions and De Novo classification.

Device

Fitbit FDA Medical Device Authorizations: A Regulatory Overview

All FDA 510(k) and De Novo authorizations for Fitbit devices through February 2025, covering cleared indications, pathways, and device classifications.

Device

FDA Approved vs. Cleared vs. Registered vs. Listed: Definitions

Definitions, permitted use, and FDA enforcement history for four commonly confused regulatory status terms across drugs, devices, and biologics.

Device

FDA Review Timelines by Pathway and Product Type

Median FDA review times from submission to decision, broken down by pathway—510(k), PMA, De Novo, NDA, and BLA—with interquartile ranges.

Device

Predicate Devices and the 510(k): Eligibility and Equivalence

How FDA defines predicate devices, what qualifies as a legally marketed predicate, and the decision logic behind substantial equivalence determinations.

Device

510(k), De Novo, or PMA: Which FDA Device Pathway Applies

Which FDA premarket pathway applies to a device, why class and predicate drive the decision, and what forces a device into De Novo or PMA.

Device

Medical Device Classes I, II, and III and Reclassification

How FDA assigns Class I, II, or III to a medical device type, what controls each class requires, and how reclassification works.

Device

Substantial Equivalence vs NSE: How FDA Decides 510(k)s

The statutory test FDA uses to clear or reject 510(k) devices, including the conditions that trigger a not substantially equivalent determination.

Device

FDA Pre-Submissions (Q-Subs): Feedback and Common Mistakes

What FDA Pre-Submissions are, what feedback sponsors receive, and the most common mistakes that make them less useful.

Device

Design Control: FDA Quality System Requirements and Citations

Design control requirements under 21 CFR Part 820 and the inspection citations FDA most commonly issues against device manufacturers.

Device

ISO 13485 and the QMSR: FDA's New Quality System Regulation

FDA replaced 21 CFR Part 820 with the QMSR, incorporating ISO 13485:2016 by reference — covering what changed and what manufacturers must do.

Device

FDA-Cleared Wearables and the General-Wellness Exemption

Which wearable and digital-health features FDA cleared as devices, and which claims drew warning letters for exceeding the general-wellness exemption.

Device

EU MDR vs. FDA: Medical Device Clinical Investigations

A side-by-side comparison of EU MDR and FDA device clinical investigation rules: authorization, clinical evaluation, informed consent, and safety reporting.

Device

MDSAP Requirements: How One Audit Satisfies Regulators in the US, Canada, Japan, Australia, and Brazil

How MDSAP's single third-party QMS audit works and how the FDA, Health Canada, ANVISA, TGA, and Japan's MHLW each accept the result.

Device

Recent FDA 510(k) Clearances for Patient-Monitoring Devices: Product Codes, Predicates, and Intended Uses

Recent FDA 510(k) clearances for patient-monitoring devices, grouped by product code, with the predicates cited and intended uses claimed.

Device

Human Factors Deficiencies in FDA Premarket Submissions: Recurring Patterns Across Device Types

The human factors and usability engineering gaps FDA most often cites in device premarket submissions, and how they vary by device type.

Device

How the TGA Regulates Software as a Medical Device (SaMD) in Australia

How Australia's TGA classifies and regulates SaMD, including clinical decision support software rules, excluded-software categories, and ARTG exemptions.

Device

FDA Expectations for Biocompatibility and Ethylene-Oxide Sterilization Residuals in Premarket Submissions

How FDA applies ISO 10993-1 biocompatibility evaluation and ISO 10993-7 ethylene-oxide residual limits in device premarket submissions.

AI & Technology

FDA Guidance on AI/ML Use in Clinical Trial Data Analysis

FDA's views on AI/ML in clinical trial data analysis, from January 2025 drug/device draft guidances and frameworks on model credibility and bias controls.

AI & Technology

Vendor-Neutral Radiology SaMD: FDA Clearances and Predicates

FDA-cleared radiology SaMD (codes LLZ, QIH, QAS, QFM) from sponsors independent of imaging hardware makers, with predicate and vendor-neutrality analysis.

AI & Technology

Software as a Regulated Medical Device vs Wellness Product

How FDA and EU frameworks determine whether software is a regulated medical device or an exempt wellness product, based on intended use and risk.

AI & Technology

FDA's Four-Criteria Test for Clinical Decision Support Software

FDA's four-criteria test for CDS device status explained, with recent clearances and where the regulatory line has shifted under the 2026 guidance.

AI & Technology

FDA Regulation of Post-Market Algorithm Changes: Predetermined Change Control Plans for AI/ML-Enabled Devices

How FDA's predetermined change control plans authorize post-market algorithm changes to AI/ML-enabled devices, with statutory basis, plan requirements, and recent authorizations.