FDA Policy/General

Latest Federal Register Notices

Guide on Bioavailability Studies for Drug Submissions
04/29/2022 Federal Register notice: FDA is making available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs — General Considerations. The document provides recommendations to sponsors planning to include bioavailability information in INDs, NDAs and supplemental NDAs. To view the notice, click here.

Draft Guide on Celiac Disease Drugs
04/28/2022 Federal Register notice: FDA is making available a draft guidance entitled Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet. The document addresses agency recommendations regarding clinical trials for such drugs. To view the notice, click here.

Guide on ANDA Waivers for pH Adjusters
04/28/2022 Federal Register notice: FDA is making available a draft guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. The document is intended to assist ANDA applicants seeking approval of a drug that is qualitatively different or quantitatively different from a reference listed drug with respect to the pH adjuster. To view the notice, click here.

Draft Guide on Trial Diversity Plans
04/28/2022 Federal Register notice: FDA has made available a draft guidance entitled Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. The document offers recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan to enroll adequate numbers of participants in compliant clinical trials. To view the notice, click here.

Gene Therapies Panel Reviews 2 bluebird BLAs
04/27/2022 Federal Register notice: FDA has announced a 6/9-10 Cellular, Tissue and Gene Therapies Advisory Committee meeting. Panel members are scheduled to discuss two bluebird bio BLAs: (1) a BLA for elivaldogene autotemcel for treating patients younger than 18 years of age with early cerebral adrenoleukodystrophy who do not have an available and willing human leukocyte antigen-matched sibling hematopoietic stem cell donor; and (2) a BLA for betibeglogene autotemcel for treating patients with β-thalassemia who require regular red blood cell transfusions. To view the notice, click here.

Device Guides on Denture Base Screws
04/27/2022 Federal Register notice: FDA has made available two final device-specific guidance documents for the Safety and Performance Based Pathway. One is on Denture Base Resins — Performance Criteria for Safety and Performance Based Pathway, and the other is on Facet Screw Systems — Performance Criteria for Safety and Performance Based Pathway. To view the notice, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome