FDA Guidance Document Update: Recently posted guidance documents on biologics, combination prodcuts, drugs, and medical devices

Recently Posted Guidance Documents on Biologics, Combination Products, Drugs, and Medical Devices

Biologics

1/10/17: Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry

Combination Products

1/10/17: Current Good Manufacturing Practice Requirements for Combination Products

1/13/17: How to Prepare a Pre-Request for Designation (Pre-RFD)

Drugs

1/9/17: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry

1/11/17: Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions

1/11/17: Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017

1/11/17: Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry

1/12/17: Nonproprietary Naming of Biological Products Guidance for Industry

1/12/17: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

1/12/17: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

1/12/17: Multiple Endpoints in Clinical Trials Guidance for Industry

1/12/17: 180-Day Exclusivity: Questions and Answers, Guidance for Industry 

1/13/17: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

1/13/17: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act

1/13/17: Referencing Approved Drug Products in ANDA Submissions Guidance for Industry

1/13/17: Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry

Medical Devices

1/13/17: Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

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