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Articles Tagged with ''FDA''
The FDA approved the first vaccine for humans against the H5N1 influenza virus, also known as the avian flu or bird flu. Read More
Bristol-Myers Squibb's (BMS) combination hypertension treatment Avalide should only be approved in the first-line treatment setting when the risks are outweighed by clinical need, according to clinical review documents released by the FDA. Read More
The FDA's Vaccines and Related Biological Products Advisory Committee will discuss lowering the minimum age for users of MedImmune's influenza vaccine FluMist at its May 16 meeting, the agency announced. Read More
A new report finds that most Americans think the FDA should have more authority over drug companies to enhance drug safety comes as Congress discusses several bills that would change the agency's standards. Read More
Four groups have sued the FDA to overturn a decision allowing OTC distribution of the contraceptive Plan B, saying the move was motivated by political pressure. Read More
The FDA has started a new program to reassess risk-benefit determinations for certain new molecular entities 18 months after they’re approved, according to CDER Director Steven Galson. Read More
Saying Seryx’s software is classified as a medical device, the FDA cited the firm in a recent warning letter for marketing its Signature Genetics program without first obtaining agency approval. Read More
Austria-based Sanochemia Pharmazeutika violated quality system regulations (QSRs) by failing to maintain procedures to prevent contamination of its Fluorognost HIV assays, according to an FDA warning letter. Read More
The FDA recently posted three separate warning letters to its website citing a sponsor, an investigator and an institutional review board (IRB) for a range of violations. Read More
FDA Commissioner Andrew von Eschenbach told attendees at an April 12 industry conference that the agency needs to face “a new reality” and become a better bridge between new treatments and patients. Read More
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