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
The US Food and Drug Administration has issued a statement detailing a new strategic framework to promote the use of real-world evidence (RWE) and real-world data (RWD) in the drug development process. 7 December 2018
Pharmaceutical
Drug-making is sometimes pictured as one of the last surviving “traditional” industries, successfully resisting waves of change that have overtaken other businesses. 5 December 2018
Pharmaceutical
The US Food and Drug Administration yesterday proposed amending its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants. 14 November 2018
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has welcomed the signing of new legislation that empowers agencies to take a range of actions to tackle the ongoing epidemic of opioid abuse in the country. 25 October 2018
Generics
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has championed the cause of generics since starting in the role nearly 18 months ago. 10 October 2018
Pharmaceutical
The US Food and Drug Administration has granted a coveted Breakthrough Therapy designation for a treatment for patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body. 6 September 2018
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement detailing steps his agency plans to take to maintain product quality and transparency at foreign drug manufacturing facilities. 6 September 2018
Pharmaceutical
The US Food and Drug Administration has provided final guidance for drugmakers on key data to be provided as part of regulatory submissions for new products. 5 September 2018
Generics
Safeguarding patient access to critical medicines is a key responsibility of the US Food and Drug Administration. To continually fulfill this responsibility, the agency has recently created a working group tasked with developing a policy framework for the importation of foreign versions of sole source medicines. Sole source medicines are FDA-approved and marketed products in the US that are manufactured by only one company, writes Dr Nicola Davies in a regular FDA blog for The Pharma Letter. 3 September 2018
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has announced new measures to help combat the growing problem of addiction to opioids in the USA. 30 August 2018
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