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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Generics
In a posting on the US Food and Drug Administration’s website, FDA Commissioner Scott Gottlieb reflects on the achievements of the agency in 2017, a record year for new product approvals. 10 January 2018
Generics
Following a record year for generic drug approvals in 2017, the US Food and Drug Administration yesterday issued the draft guidance for industry “Good ANDA Submission Practices,” which highlights common, recurring deficiencies in Abbreviated New Drug Applications (ANDAs) that may lead to a delay in the approval of an ANDA. 4 January 2018
Pharmaceutical
After a long-running investigation, the US Food and Drug Administration has finally concluded that asthma can be treated with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) just as safely as with ICS alone. 21 December 2017
Pharmaceutical
US FDA commissioner Scott Gottlieb has provided a review of current scheduled regulatory developments within the purview of the agency. 15 December 2017
Pharmaceutical
Speaking before a congressional committee in the US House of Representatives, FDA Commissioner Scott Gottlieb confirmed Thursday that his agency is honing in on new ways to approve certain drugs faster. 1 December 2017
Generics
US FDA commissioner Scott Gottlieb has announced new measures to promote the development of generic abuse-deterrent formulation opioids. 22 November 2017
Generics
The US Food and Drug Administration has started including patent submission dates in the so-called Orange Book, the record of approved drug products. 22 November 2017
Biotechnology
The International Society for Cellular Therapy has welcomed the US FDA’s newly-released comprehensive Regenerative Medicine Policy Framework. 20 November 2017
Biosimilars
FDA Commissioner Scott Gottlieb has announced new draft guidance for the pharmaceutical industry affecting Risk Evaluation and Mitigation Strategies (REMS) submissions. 9 November 2017
Pharmaceutical
Today, November 1, marks the coming into operation of further aspects of the mutual recognition agreement between the European Union and the United States to recognize inspections of manufacturing sites for human medicines conducted in their respective territories. 1 November 2017
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