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December 2019
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided in December 2019.
Finalized Draft Guidance Documents:
Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review Guidance for Industry- Technical Specifications Document 20Dec2019
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Considerations for the Development of Dried Plasma Products Intended for Transfusion Guidance for Industry (Published 19Dec2019)
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COMPLIANCE POLICY GUIDE (CPG), Chapter 2 – Biologics (13Dec2019)
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New Draft Guidance Documents:
Requesting FDA Feedback on Combination Products Guidance for Industry and FDA Staff DRAFT GUIDANCE (Published 23Dec2019)
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Importation of Certain FDA2 Approved Human Prescription Drugs, 3 Including Biological Products, under 4 Section 801(d)(1)(B) of the Federal 5 Food, Drug, and Cosmetic Act: 6 Draft Guidance for Industry (Published 23Dec2019)
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Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry DRAFT GUIDANCE (Published 20Dec2019)
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Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry DRAFT GUIDANCE (18Dec2019)
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Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff DRAFT GUIDANCE (Published 13Dec2019)
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FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act Guidance for Industry DRAFT GUIDANCE (Published 12Dec2019)
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Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry DRAFT GUIDANCE (Published 09Dec2019)
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Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry DRAFT GUIDANCE (Published 04Dec2019)
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Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers (Published 20Dec2019)
WHO Prequalifies its First Biosimilar (Published 19Dec2019)
The Brave new World of Social Media: Regulatory Perspective on Hashtags and Facebook Messenger (18Dec2019)
Drug Importation Plans: Lots of Exclusions, Unclear Timeline (Published 18Dec2019)
FDA Supports Budget Bill’s Changes to Chemically Synthesized Polypeptides (Published 18Dec2019)
Drug Development Tools: FDA Drafts Guidance on Qualification Process (Published 13Dec2019)
Hahn Wins Senate Confirmation to be 24th FDA Commissioner (Published 12Dec2019)
When FDA Requires Pediatric Studies for New Cancer Drug Submissions: New Draft Guidance (Published 12Dec2019)
USMCA Drops Biologic Exclusivity Provisions for Mexico and Canada in Final Deal (10Dec2019)
Global Pediatric Drug Development (Published 10Dec2019)
US Biosimilar Launches About to Turn a Corner (Published 09Dec2019)
Optimizing the Review Process of Advertising and Promotional Communications (Published 09Dec2019)
FDA Drafts Recommendations for IC/BSP Drug Development (Published 04Dec2019)
Form FDA 1572: Challenges and Opportunities (Published 03Dec2019)
FDA Finalizes Guidance on Adaptive Trial Designs (Published 02Dec2019)
EC Explains What it Means to Authorize Clinical Trials With Conditions (Published 02Dec2019)
The Transformation of Digital Health: What it Means for Regulatory Professionals (Published 02Dec2019)
E Pluribus Unum – The Future of Medical Writing (Published 02Dec2019)
- Read our infographic to Understand FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER
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