Articles

Real World Evidence in FDA Drug Approvals: Examples and Reasons for Exclusion from Prescribing Information

Comprehensive analysis of specific examples where Real World Evidence (RWE) and Real World Data (RWD) were considered or excluded from FDA drug labeling, including detailed FDA rationale for inclusion and exclusion decisions.

CDER Deficiencies and Information Requests for Injectable Drugs 2024-2025

Comprehensive analysis of CDER's specific requests for information and deficiencies regarding injectable drugs and delivery devices disclosed in review memos from 2024 and 2025, covering drug quality tests and device ISO requirements.

CDER Questions in BLA Reviews for Autoinjectors and Prefilled Pens

Explore specific questions CDER has asked in recent BLA reviews for autoinjectors and prefilled pens, focusing on design verification, shipping validation, and more.

FDA Information Requests in BLA Reviews for Part 4 Compliance

Analyze common FDA information requests during BLA reviews regarding Part 4 compliance, focusing on management responsibility, design controls, CAPA, and purchasing controls.

FDA Requirements for URRA Revisions in BLA and NDA Reviews

Documented instances from recent FDA reviews where revisions to Use-Related Risk Analysis (URRA) submissions were explicitly required, including specific examples and FDA rationale.

FDA Preclinical Testing Expectations for Large Molecule Drugs in IND Applications

Comprehensive analysis of FDA preclinical testing requirements for biologics in IND applications, including toxicology studies (rodent and non-rodent), pharmacology evaluations, reproductive toxicity assessments, GLP compliance, species selection considerations, and regulatory flexibility for exploratory INDs.

Common FDA Feedback in Type B Meeting Minutes for Solid Tumor IND Preparation

Analysis of recurring FDA feedback themes from Type B meeting minutes for solid tumor therapies preparing IND submissions, covering preclinical data requirements, clinical trial design, safety assessments, manufacturing considerations, and regulatory alignment strategies.

Recent Energy-Based Medical Devices Entering the Market

Comprehensive overview of energy-based medical devices that have recently received FDA approval or clearance, covering radiofrequency, ultrasound, laser, and microwave technologies across therapeutic applications including aesthetics, oncology, and other medical specialties.

FDA Acceptance of Out-of-US Real World Evidence Data for De Novo Device Classifications

Detailed analysis of documented cases where the FDA has accepted Real World Evidence (RWE) data collected outside the United States to support De Novo device classification requests. This review examines specific examples, FDA rationale for acceptance, data quality considerations, and regulatory precedents for using international RWE in De Novo submissions.

FDA ISO 11040 Requirements for Autoinjectors and Prefilled Pens

Explore FDA requirements for prefilled syringe performance testing per ISO 11040 for autoinjectors and prefilled pens, including leakage and flange break resistance.

Autoinjector Shelf Life Extension Studies

Review FDA expectations for shelf life extension studies specifically for autoinjector combination products.

FDA ISO 11608 Requirements for Prefilled Syringes

Analyze FDA review documents to determine explicit requirements for ISO 11608 testing and conformance for prefilled syringes and PFS/NSD products.

EMA Non-Clinical Data Requirements for Human Polyvalent Immunoglobulins

Examine what non-clinical toxicity data the EMA has accepted for human polyvalent immunoglobulin products, including study omissions and alternative approaches.

FDA Requirements for Retroviral and Lentiviral Vectors in T-Cell Gene Therapy BLA Approvals

Comprehensive analysis of FDA requirements for BLA approval of retroviral and lentiviral vectors used to genetically modify T-cells, covering integration site analysis, long-term follow-up, manufacturing controls, and risk mitigation strategies for insertional oncogenesis.

FDA Information Requests for Autoinjector Testing and Performance

Comprehensive analysis of FDA information requests to BLA and NDA applicants regarding autoinjector testing and performance since 2022, including examples where the FDA explicitly accepted applicant responses.

Preclinical Toxicity Endpoints for Large Molecule Drugs in FDA Approval

Comprehensive analysis of toxicity endpoints used in preclinical testing for large molecule drugs seeking FDA approval, including organ toxicity assessments, clinical pathology parameters, histopathology evaluations, GLP compliance requirements, and ICH S6 guidance alignment for biologics.

Patient-Reported Outcomes in FDA Prescribing Information

Examine CDER's practices regarding the inclusion of patient-reported outcomes in prescribing information documents over the past five years.

Autoinjector Patient Handling Studies

Learn about FDA expectations for patient handling studies for autoinjector combination products.

Autoinjector and Prefilled Pen Usability Studies in EMA CTIS

Analyze the CTIS database to identify clinical trial protocols that include actual use or patient usability studies of autoinjectors or prefilled pens, specifically focusing on studies where patients themselves perform the injections rather than healthcare professionals.

Primary Endpoints for a Stage 3 Clinical Trial for Huntington's Disease

Comprehensive analysis of primary endpoints used in stage 3 clinical trials for Huntington's disease drugs, including clinical rating scales (UHDRS, cUHDRS, TFC, TMS), cognitive assessments, biomarkers (mHTT, NfL, tau), and imaging measures.

Stage 2 Clinical Trial Primary Endpoints for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Comprehensive analysis of primary endpoints for stage 2 trials in R/M HNSCC, including objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety assessments, patient-reported outcomes, and biomarker-based measures.

Clinical Trials for Point-of-Care Diagnostic Devices: Recent Studies

Comprehensive analysis of clinical trials conducted in recent years evaluating point-of-care diagnostic devices across diverse applications including infectious diseases, cardiometabolic conditions, and respiratory illnesses, highlighting study designs and device performance.

In-Process Bioburden Limits for Drug Products

Understand FDA expectations for in-process bioburden limits in drug product manufacturing based on recent regulatory actions.

Dupixent Prescribing Information Changes: How Supplied Section Updates 2020-2024

Comprehensive chronological analysis of all changes to Dupixent's FDA-approved prescribing information from 2020-2024, with detailed focus on How Supplied section updates including new auto-injector presentations, pre-filled pen additions, and regulatory label modifications.

Ozempic Prescribing Information Changes: How Supplied Section Updates Since 2022

Complete chronological review of all documented changes to Ozempic's approved prescribing information since 2022, including How Supplied section modifications with new pen presentations, strength additions, discontinuations, and updated storage instructions across FDA and EMA approvals.