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The FDA has issued two draft guidances focused on requirements for drug and biological approvals — one on formal meetings and one on alternative methods the agency may use to assess manufacturing facilities named in an NDA or BLA. Read More
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 that also includes several clarifications. Read More
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, speaking at the 2023 PDA/FDA Joint Regulatory Conference on Tuesday. Read More
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 shortages, warns Patrizia Cavazzoni, director of the FDA’s CDER, speaking at the 2023 PDA/FDA Joint Regulatory Conference. Read More
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 forum held by the Alliance for a Stronger FDA. Read More
The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling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, or if, the corresponding software function should be described in the prescribing information (PI). Read More
The FDA has offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance on whether a single trial plus confirmatory evidence will suffice for a development program. Read More