domingo, 16 de agosto de 2015

Recently posted FDA guidance on drugs, medical device user fees, 510(k)s, nanomaterials, risk information in advertising, and outsourcing facilities

 Recently posted guidance documents

7/31/15: Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs Guidance for Industry

8/3/15: FY 2016 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

8/3/15: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act

8/4/15: Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff

8/4/15: Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen

8/5/15: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs

8/5/15: GFI #220 - Use of Nanomaterials in Food for Animals

8/11/15: Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Guidance Document Search

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