Drug Safety

Drug manufacturing in the EU would grind to a halt in under three years if a proposal to restrict per- and polyfluoroalkyl substances in the European Economic Area is implemented in its current form, says industry group EFPIA.

FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.

US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.

CDER reviewers don’t buy that safety concerns with exenatide implant ITCA 650 are in line with the risks labeled for already approved GLP-1 agonists for type 2 diabetes – even other formulations of the same drug – potentially due to unique considerations associated with Intarcia’s delivery method.

The European Medicines Agency is to recommend whether the marketing authorization for Currax’s weight management drug should be maintained, varied, suspended or revoked.

The European Medicines Agency’s pharmacovigilance committee said its safety review of topiramate took account of available data including three recent observational studies.

RCORE designation means SAHPRA can support training and exchange programs as part of pan-African regulatory strengthening moves.

Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.

Pakistan’s medicines regulator is disappointed that so few drug companies have complied with a requirement notify to the National Pharmacovigilance Centre about their designated pharmacovigilance officers. 

Since FDA has approved Sezaby there is no reason for continued use of unapproved phenobarbital sodium products, firm tells FDA. Sun cites risks to neonates from three excipients in these products. The seizure drug has been marketed since 1940.

Shared REMS, diverse confirmatory trials and manufacturing delays are among the highlights in the latest US FDA drug approval news from the Pink Sheet’s US FDA Performance Tracker.

Timeline depicts the 27-year history of mifepristone from new drug application submission through an advisory committee vote, REMS changes, and legal challenges. With the product headed back to the Supreme Court, FDA's approval authority in general is also on the docket.

Initial results from a study indicate that children born to men taking valproate medicines are at an increased risk of having neurodevelopmental disorders, but “important limitations” and “errors” with the data highlight the need for further analysis.

If ruling against US FDA by 5th Circuit is enacted, access to the medication abortion would revert to pre-2016 restrictions, meaning the product would be indicated for a maximum gestational age of forty-nine days and would need to be administered in person.

Chart encapsulates the fundamental questions in Alliance for Hippocratic Medicine v. FDA and the arguments of both parties on standing to sue, the agency’s approval standards, REMS changes, and the Comstock Act of 1873.

Albumin medicinal products manufactured using plasma from UK donors pose minimal, if any, risk of infecting recipients with variant Creutzfeldt-Jakob disease, the UK regulator has determined.