Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants, November 18, 2015, Federal Register.
Guidance on Qualification of Biomarker—Galactomannan in Studies of Treatments of Invasive Aspergillosis, November 13, 2015, Federal Register.
Guidance for Industry: Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment, November 3, 2015, Federal Register.
(Revised) Guidance for Industry: DSCSA Implementation: Product Tracing Requirements for Dispensers—Compliance Policy, November 2, 2015, Federal Register.
Draft Guidance on Progesterone, November 2, 2015, Federal Register. Comments are due January 4, 2016.
Draft Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, November 2, 2015, Federal Register. Comments are due December 17, 2015.
Draft Guidance for Industry and FDA Staff: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products, October 30, 2015, Federal Register. Comments are due April 29, 2016.
Draft Guidance for Industry: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation, October 30, 2015, Federal Register. Comments are due December 29, 2015.
Draft Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act, October 27, 2015, Federal Register. Comments are due December 28, 2015.
Draft Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, October 27, 2015, Federal Register. Comments are due December 28, 2015.
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