Archive for January 2024

Strong nonclinical testing should underpin development programs for both gene editing (GE) products and chimeric antigen receptor (CAR-T) cellular products, according to two new final guidances issued by the FDA. Source: Drug Industry Daily

During its second town hall on reducing the use of ethylene oxide (EtO) to sterilize medical devices, FDA officials announced the creation of a dedicated EtO “tiger team” with expertise in regulatory science, regulatory review, policy, supply chain, and incident response. Source: Drug Industry Daily

In a move that caught many industry experts unaware, the U.S. government last week announced the sale of the Federal Helium Reserve to a private company, despite warnings about the risk of shortage for critical helium that powers magnetic resonance imaging (MRI) machines. Source: Drug Industry Daily

Manufacturers with tentatively approved ANDAs can look to a recently issued FDA final guidance for information on how to prepare and submit amendments as well as make requests to get faster final approval. Source: Drug Industry Daily

The FDA has revised a previous draft on its current approach to conducting remote regulatory assessments (RRA), incorporating public comments as well as recent amendments to the Food, Drug and Cosmetic Act. Source: Drug Industry Daily

Generic drugmakers Apotex, Heritage and Breckenridge have agreed to settle for a combined $45 million over allegations that they colluded to fix prices. Source: Drug Industry Daily

Over the past week, the FDA issued final guidance on revising ANDA labeling, draft guidances on metallic coatings and/or calcium phosphate coatings on orthopedic devices and conducting remote regulatory assessments. The agency also announced a meeting of the circulatory system devices panel of the medical devices advisory committee and posted best practices for FDA staff…

The FDA is offering drugmakers the opportunity to become involved in an agency effort to find ways to evaluate quality management maturity (QMM) by using a prototype assessment protocol. Source: Drug Industry Daily

While secondary T-cell cancers following CAR-T cell therapy are relatively rare adverse events, the FDA wants its new boxed warning labeling changes for the drugs to encourage more data on outcomes, agency officials said in an editorial. Source: Drug Industry Daily

The Department of Justice (DOJ) and HHS issued a joint letter to state Medicaid administrators urging them to act in accordance with the Americans with Disabilities Act (ADA) and allow access to life-saving hepatitis C medications to people who have both hepatitis C and substance use disorder. Source: Drug Industry Daily