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Nieuwsfeed
- About CDER Small Business and Industry Assistance (SBIA)
- Protocol Amendments Don’t Have to Create Chaos
- Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026
- Patent Certifications and Suitability Petitions
- Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
- Sponsor’s Guide to IRB Approval: What Every Sponsor Needs to Know Before Submitting a Study
- CDER Small Business and Industry Assistance (SBIA) Learn
- CDER SBIA Chronicles
- ALTUVIIIO
- FDA Pharmaceutical Quality Training Modules
- Q&A with Advarra’s Director of Training in IRB Services Lori Young
- Helpful Webinars and Other Resources for Generic Drug Manufacturers
- FDA Rare Disease Innovation Hub
- Rare Diseases at FDA
- Laboratory Information Bulletins
- Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma - 05/12/2026
- Major pharmacology journals flag another 15 papers by scientist facing criminal probe
- Animal Welfare, Testing and Research of FDA-Regulated Products
- Gut microbiome changes may signal Parkinson’s disease risk
- New Approach Methodologies (NAMs)
- GDUFA IV: Fiscal Years 2028 – 2032
- Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers - 04/15/2026
- Patient-Focused Drug Development
- Generic Drug User Fee Amendments
- Generic Drug Facilities, Sites and Organization Lists
- Establishing Impurity Specifications for Antibiotics
- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
- Frequently Requested or Proactively Posted Drug-Specific and Other Records
- Marcus Research Laboratory, Inc. - 615153 - 10/02/2024
- MMC Healthcare Ltd. - 684644 - 09/24/2024
- Diamond Chemical Co., Inc. - 687078 - 09/06/2024
- Clean Solutions LLC - 686995 - 09/06/2024
- Supercore Products Group, Inc. - 690510 - 09/26/2024
- Little Moon Essentials, LLC - 677260 - 09/17/2024
- Makra Kozmetika D.O.O. - 684125 - 09/26/2024
- The RW Daily: 10 years ago, Elisabeth Bik published a preprint heard around the world. And Chinese universities and research integrity.
- “Skin patch helped me spot lung rejection” says beneficiary
- Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center
- The Infinity Machine
- 10 years ago, Elisabeth Bik published a preprint heard around the world
- Quality Metrics for Drug Manufacturing
- Weekend reads: An alternative to the impact factor in China; the clinical trials of six ‘superretractors’; Retraction Watch goes to Capitol Hill
- Weekend reads: An alternative to the impact factor in China; the clinical trials of six ‘superretractors’; Retraction Watch goes to Capitol Hill
- Reminder: FDA Approval Is Not Synonymous With Commercial Success
- FDA Small Business Regulatory Education for Industry (REdI) Conference “Focus on CGMPs and FDA Inspections” Summer 2015 Presentation Slides
- Study Data Technical Conformance Guide - Technical Specifications Document
- FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary
- FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary
- FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary
- Regulatory Submissions in Electronic Format for CBER-Regulated Products
