Drug
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.
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
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
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 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.
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
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
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
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
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
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
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.
Device
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.
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
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.
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
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
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.
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
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.
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'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.
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
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 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
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
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.
Combination Product
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.
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
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
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
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
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
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
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
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 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
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.
Biologic
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.
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
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
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 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
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 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.