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
Pharmaceutical
By Dr Nicola Davies
In 2009, the US Food and Drug Administration outlined steps to improve its transparency program in three phases.1 26 February 2018
Pharmaceutical
At a public meeting in Washington DC, FDA Commissioner Scott Gottlieb outlined some of the ways the US medicines regulator is working to combat the opioid addiction epidemic, RAPS reports. 23 February 2018
Pharmaceutical
Recognizing an “urgent need for new medical treatments” for many neurological disorders, the FDA says it's revising its product review team structure and changing the way it communicates scientific and regulatory guidance. 16 February 2018
Pharmaceutical
The US Food and Drug Administration has issued an approving statement relating to President Trump’s budget proposal, noting the inclusion of “about $400 million in additional funding,” which would in part “further promote innovation and competition.” 14 February 2018
Generics
Shortly after the US Government Accountability Office (GAO) issued a report accusing the FDA of failing to include product-specific guidance documents, the agency has stepped up its efforts with 57 such documents. 9 February 2018
Pharmaceutical
FDA commissioner Scott Gottlieb issued a warning on Tuesday about the herbal remedy kratom, saying the latest scientific analyses provide strong evidence of the compounds’ opioid properties. 7 February 2018
Generics
Many patients struggle to gain access to low-cost medications, motivating the US Food and Drug Administration to develop the Drug Competition Plan, which aims to broaden access to generic drugs, notes Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter. This plan has three major components:1 26 January 2018
Pharmaceutical
The US Food and Drug Administration has launched a joint initiative with the US Department of Defence to expedite development of medical products for use by the US military. 17 January 2018
Generics
FDA Commissioner Scott Gottlieb has responded to a US Government report which criticised the unpredictability of changes the agency makes to guidance on complex generics. 17 January 2018
Pharmaceutical
According to US Food and Drug Administration regulations, the regulatory agency may refuse to file a new drug application (NDA) or biologics license application (BLA) when either is deemed incomplete, writes Dr Nicola Davies in her monthly blog for The Pharma Letter. 10 January 2018
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