FDA Policy/General

Latest Federal Register Notices

Drug Distribution Security Public Meeting
10/14/2021 Federal Register notice: FDA has announced an 11/16 virtual public meeting entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA).” The meeting is intended to provide stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to system attributes necessary to enable secure tracing of product at the package level. To view the notice, click here.

Some Class 1 Devices Exempt from UDI
10/13/2021 Federal Register notice: FDA has made available a draft guidance entitled Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. The document identifies certain Class 1 devices for which FDA does not intend to enforce Global Unique Device Identification Database submission requirements. To view the notice, click here.

Guide on Drug Continuous Manufacturing
10/13/2021 Federal Register notice: FDA has made available a draft guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Products. The International Council for Harmonization document provides clarification on continuous manufacturing concepts and describes scientific approaches and regulatory considerations. To view the notice, click here.

Panel to Review Pfizer Covid Vaccine in Kids
10/12/2021 Federal Register notice: FDA has announced a 10/26 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to review and discuss Pfizer-BioNTech’s emergency use authorization amended request to administer their Covid-19 mRNA vaccine to children aged five through 11 years of age. 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