In a pair of final guidances published Friday, the FDA outlined acceptable reasons for requesting an extension for responding to a Complete Response Letter (CRL) and provided answers to frequently…
The FDA announced Friday that remote regulatory assessments (RRA) have proven to be a valuable tool and the agency will continue to use them beyond the COVID-19 pandemic. Source: Drug…
It’s looking more and more likely that Congress will miss its deadline to pass a user-fee reauthorization bill — potentially forcing the agency into sending out furlough notices to its…
The FDA issued a proposed rule on Friday that would require drugmakers to use a standardized 12-digit National Drug Code (NDC) format with three distinct segments. Source: Drug Industry Daily
Countries participating in this year’s Pangea XV, an international illicit drug crackdown, made more than 7,800 seizures of illicit and misbranded medicines worth $11 million and totaling 3 million individual…
The European Medicines Agency is calling for public comment on the International Council for Harmonization (ICH) new draft guidance on conducting drug interaction studies. Source: Drug Industry Daily
Novartis no longer plans to submit PD-1 checkpoint inhibitor tislelizumab for approval in the U.S. as a monotherapy for nonsmall-cell lung cancer (NSCLC). Source: Drug Industry Daily
In a worrying sign for several drug candidates, Roche said it has halted five phase 1 and 2 trials evaluating therapies for major diseases including cancers, asthma and a metabolic…
Amneal Pharmaceuticals subsidiary Impax Laboratories has agreed to pay $145 million to settle allegations it partnered with Endo International to illegally delay the launch of a generic of Endo’s opioid…
It’s getting crowded on the cell therapy bandwagon — and it won’t be able to hold many more passengers, according to a market analysis by GlobalData. Source: Drug Industry Daily