FDA Guidance Documents Update

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Recently posted guidance documents

These draft and final guidance documents were published by the Food and Drug Administration in December 2014:

12/1/14: SUPAC: Manufacturing Equipment Addendum

12/2/14: Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff

12/2/14: Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff

12/3/14: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format

12/4/14: How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD

12/8/14: General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products

12/8/14: DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

12/9/14: Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format

12/10/14: VICH GL35 - Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data

12/11/14: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff

12/17/14: Providing Submissions in Electronic Format -- Standardized Study Data

12/19/14: Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff

12/22/14: Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers Draft Guidance for Industry and Food and Drug Administration Staff

12/23/14: DSCSA Implementation: Product Tracing Requirements — Compliance Policy

12/30/14: Radiation Biodosimetry Devices - Draft Guidance for Industry and Food and Drug Administration Staff

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