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Jun 14

New FDA Guidance’s For May 2019

Special Interest Guidances/Information Date Posted
Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff – Final Guidance 30 May 2019
Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;: Guidance for Industry – Final Guidance 24 May 2019
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry – Draft Guidance 21 May 2019
Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling – Draft Guidance 17 May 2019
Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry – Final Guidance 09 May 2019
Determining Whether to Submit an ANDA or a 505(b)(2) Application – Final Guidance 09 May 2019
Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: Study Elements and Considerations – Final Guidance 09 May 2019
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry: Guidance for Industry – Final Guidance 09 May 2019
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis: Guidance for Industry – Final Guidance 09 May 2019
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57): Guidance for Industry and Food and Drug Administration – Final Guidance 08 May 2019
Clinical Lactation Studies: Considerations for Study Design – Draft Guidance 08 May 2019
Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk – Final Guidance 08 May 2019
Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff – Final Guidance 08 May 2019
Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 08 May 2019
Policy Clarification for Certain Fluoroscopic Equipment Requirements: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 08 May 2019
Postapproval Pregnancy Safety Studies Guidance for Industry – Draft Guidance 08 May 2019
Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics – Draft Guidance 08 May 2019
Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 08 May 2019
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 07 May 2019
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry – Draft Guidance 03 May 2019
Upcoming Meetings (* = New)
  May 14, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
  May 30-31, 2019: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
  June 6, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement
  June 11-12, 2019: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee
  June 19-20, 2019: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
  June 20, 2019: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

 

Last updated: 13 June 2019