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The FDA has no obligation to educate companies about what is and isn’t fair game during an inspection and there is no equivalent of a “Miranda warning” that cops must give when detaining individuals, says inspections expert David Chesney, principal of DL Chesney Consulting.

cGMP violations are occurring at multiple unapproved human cell, tissue, and cellular and tissue-based product manufacturers.

As lawmakers fail to reach a deal to extend funding past the critical deadline of Sept. 30, the possibility of a government shutdown looms, threatening operations at the FDA and other government agencies.

Novartis’ recall of one lot of its Sandimmune oral solution (cyclosporine) due to crystal formation has been deemed a class 1 recall by FDA, the most serious type of recall, because use of the drug may cause serious injury or death.

Clinical development timelines mean it will take companies approximately five years to recover initial investment.

The FDA smacked Novo Nordisk, producer of blockbuster weight loss drug semaglutide, the active ingredient in Wegovy and Ozempic, for quality control deficiencies discovered at its Clayton, N.C., plant, including microbiological contamination, following an inspection conducted in May 2022.

Companies selling unapproved biologics products is a major ongoing concern for the FDA’s CBER, says an agency consumer safety expert, speaking at the 2023 PDA/FDA Joint Regulatory Conference on Wednesday.

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.

The FDA is working on cultivating educational resources on AI/ML for stakeholders.

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.

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.

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.

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.

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).

An updated HHS policy will include specific provisions prohibiting political interference.

In August, Oncopeptides appealed the FDA’s formal request that the company withdraw the drug from the market.

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.

Drugmakers misused Orange Book listings to improperly protect patents.

Committee chair says FDA may not look domestically for production before turning outside the U.S. during a drug shortage.

The FDA released two draft guidances for biosimilar manufacturers — one on labeling that focuses on prescribing information and the other on the FDA’s licensure requirements.