The FDA has expanded the scope of its guidance on conducting clinical trials during the COVID-19 pandemic to apply to public health emergencies (PHE) and other disasters, issuing final guidance…
ARS Pharmaceuticals announced that the FDA issued a complete response letter (CRL) on its NDA for neffy (epinephrine nasal spray) after having received a recommendation for approval from the agency’s…
CDRH, as part of its MDUFA V commitments, has released a draft plan to further its work toward globally harmonized medical device regulation, policy and practices as part of the…
Despite impressive gains in recent years, investment in gene therapy products is at a critical juncture due to current manufacturing challenges, among other factors, says Peter Marks, director of CBER,…
While the U.S. has seen a decrease in the number of shortages, the country has seen an increase in the complexity of shortages and the time necessary to mitigate these…
Applications that use AI and machine learning (ML) have a unique dependence on data, said the FDA’s Digital Health Center of Excellence Acting Deputy Director MiRa Jacobs at Tuesday’s open…
Pandemics. War. Political upheaval. Severe weather. Availability of energy supplies. Any of these can kink up the supply chain, making it difficult (and sometimes impossible) to get drugs to the…
Celgene and Bristol Myers Squibb (BMS) have used a pattern of unlawful patents to extend a monopoly in the market for Pomalyst (pomalidomide), a blockbuster drug used in the treatment…
The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling and how,…
The best way to design trials around an artificial womb intended to better regulate body temperature and foster safer lung development in extremely premature infants (EPI) is the focus of…