- 12/20/2019 - Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff
- 12/19/2019 - Considerations for the Development of Dried Plasma Products Intended for Transfusion: Guidance for Industry
- 12/18/2019 - Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry
- 12/18/2019 - Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry
- 12/16/2019 - 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff
- 12/16/2019 - Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff
- 12/16/2019 - Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff
- 12/16/2019 - eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff
- 12/16/2019 - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff
- 12/16/2019 - Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals
- 12/16/2019 - Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA Staff
viernes, 20 de diciembre de 2019
Recently Posted Guidance Documents
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