Latest FDA News
Pharmaceutical
The US Food and Drug Administration (FDA) is reopening the comment period for the Federal Register notice (FRN), “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments” due to high interest from industry. 31 December 2024
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Latest News & Features of interest to FDA
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period for Daiichi Sankyo’s (TYO: 4568) quizartinib. 5 April 2019
Pharmaceutical
The US Food and Drug Administration has announced new final guidance on HIV prevention, following US President Donald Trump’s recently-announced effort to eliminate the HIV epidemic within America. 20 March 2019
Pharmaceutical
Research funded by the US Food and Drug Administration suggests that people who view drug adverts are more likely to respond to a claim about a product’s popularity than its efficacy. 18 March 2019
Generics
Research shows some 79% of the American public view the cost of prescription drugs as unreasonable, and lawmakers and regulators are increasingly convinced the industry charges too much for its products. 8 March 2019
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement outlining his agency’s efforts to stop the illegal importation of drugs and control the drug supply chain. The agency will also seek more more focused New Drug Applications (NDA) for opioid products. 12 February 2019
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement outlining steps the agency is taking to reform the process for public warnings on product recalls. 8 February 2019
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has provided an update on the agency’s new actions under the Digital Health Precertification (Pre-Cert) Program. 8 January 2019
Pharmaceutical
Following a review of fluoroquinolone antibiotics, the US Food and Drug Administration has issued a statement regarding an association with a rare but serious side effect. 21 December 2018
Pharmaceutical
The US Food and Drug Administration has issued new guidance related to clinical trial endpoints in oncology, providing recommendations for applicants seeking approval for novel therapies. 20 December 2018
Generics
The US Food and Drug Administration has said it is withdrawing a proposed rule which would have allowed generic drugmakers to independently update and distribute new safety information in drug labels. 14 December 2018
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