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The FDA has issued draft guidance clarifying the regulatory requirements for collecting and providing portions of official samples of drugs, foods or cosmetics that may be needed for the agency’s analysis or any litigation involving the items. Read More
The FDA has slapped Eli Lilly with an Untitled Letter over what it calls a “misleading” and “particularly concerning” ad the company posted on Instagram for its type 2 diabetes drug Trulicity. Read More
The FDA has released draft guidance for applicants and holders of an abbreviated new drug application (ANDA) on updating their labeling after revisions to the approved labeling of a reference listed drug (RLD) on which a generic drug is based. Read More
Pfizer and OPKO Health drew a Complete Response Letter (CRL) from the FDA for their Biologics License Application (BLA) for Ngenla (somatrogon), an injectable, long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Read More
“Giving foreign drug manufacturers in countries like China a ‘heads up’ before facility inspections … makes about as much sense as relying on the [Chinese Communist Party] to make these critical goods in the first place,” said Sen. Joni Ernst (R-Iowa). Read More
Kura Oncology said Friday that the FDA has lifted a partial clinical hold placed on the company’s early-stage clinical trial of its drug candidate, KO-539, in patients with relapsed or refractory acute myeloid leukemia (AML). Read More
The UK’s National Institute for Health and Care Excellence (NICE), the body that evaluates medicines for use by the National Health Service (NHS), is changing the way it makes judgments on treatments. Read More
Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through fiscal year 2020 to fiscal year 2021, according to the latest data posted on the agency’s “dashboard” — which tracks how well the agency is living up to its review commitments under the user fee programs. Read More