«

Apr 10

2019 March FDA Guidances

Special Interest Guidances/Information Date Posted
Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice – Final Guidance 27 Mar 2019
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research – Final Guidance 25 Mar 2019
Rare Diseases: Natural History Studies for Drug Development – Draft Guidance 22 Mar 2019
Pediatric HIV Infection: Drug Development for Treatment – Final Guidance 19 Mar 2019
Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis – Final Guidance 19 Mar 2019
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) – Final Guidance 15 Mar 2019
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers – Draft Guidance 14 Mar 2019
Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals – Final Guidance 14 Mar 2019
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products – Final Guidance 14 Mar 2019
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials – Final Guidance 12 Mar 2019
Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients – Draft Guidance 12 Mar 2019
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies – Draft Guidance 12 Mar 2019
Cancer Clinical Trial Eligibility Criteria: Brain Metastases – Draft Guidance 12 Mar 2019
Nonproprietary Naming of Biological Products – Draft Guidance 07 Mar 2019
Upcoming Meetings (* = New)
* April 25, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement
* April 26, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement
* May 8, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

Last updated: 09 April 2019