Article Summary:
The ongoing government shutdown is impacting the FDA, with reports that the White House has begun laying off furloughed federal health staff. Over 32,000 HHS employees have already been furloughed. The shutdown has also resulted in changes at the Center for Biologics Evaluation and Research (CBER), with the former director Peter Marks joining Eli Lilly and Vinay Prasad taking over as the new acting director, making staffing changes.
The FDA has taken several regulatory actions, approving new drugs for idiopathic pulmonary fibrosis and cutaneous squamous cell carcinoma. It has also approved a biosimilar to Eylea. However, the agency is facing challenges, such as a lawsuit filed by Louisiana to prohibit the mailing of abortion pills within the state. Additionally, the FDA issued a warning letter to a company over unapproved claims about its laser devices.
The text also mentions upcoming events, such as the rescheduling of a CDC vaccine panel meeting and the FDA’s draft guidance on biosimilarity reaching OMB review. It also discusses a controversial decision regarding Biohaven Pharmaceuticals’ drug for spinocerebellar ataxia, which could provide insights into the FDA’s regulatory flexibility.
Finally, the article notes that the International Council on Harmonisation (ICH) has released a training module for interpreting and applying the ICH E6(R3) guideline on good clinical practices.
Overall, the text covers a range of FDA-related news, including the impact of the government shutdown, regulatory actions, upcoming events, and challenges facing the agency.