Recently Posted Guidance Documents

Recently Posted Guidance Documents

2/6/2020 - Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry 2/5/2020 - Use of Serological Tests to Reduce the Risk of Transfusion-Transmitted Human T-Lymphotropic Virus Types I and II (HTLV-I/II): Guidance for Industry 2/5/2020 - Withdrawn CDER Product Specific Guidances 2/4/2020 - Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy 2/3/2020 - Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry 2/3/2020 - Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels