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
American Pharma News
Insights
Company Spotlight
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.
Latest News & Features of interest to FDA
Pharmaceutical
Dr Nicola Davies debates the efficacy of US Food and Drug Administration approvals given the speed over safety angle. 30 August 2017
Biotechnology
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has hit out against false prophets and dangerous players in the much-hyped world of stem cell therapies and their use in regenerative medicine as he outlined plans for a new comprehensive policy framework. 29 August 2017
Pharmaceutical
The European Commission, the US Food and Drug Administration and the European Medicines Agency have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. 23 August 2017
Pharmaceutical
While the signing of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) was not the the action of US President Donald Trump that garnered most headlines last week, it has undoubted importance for the drug development industry. 22 August 2017
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb says there’s perhaps no more important mandate that the FDA has than safeguarding the health and safety of children. 22 August 2017
Pharmaceutical
On Friday, US President Donald Trump signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA) into law, which in effect reauthorized the Prescription Drug User Fee Act (PDUFA) and user fees for biosimilars, generic drugs and medical devices. 19 August 2017
Pharmaceutical
The US Food and Drug Administration has issued a statement requesting input on a possible change to the rules governing the way statements about drug safety are presented in pharmaceuticals advertising. 18 August 2017
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has responded to yesterday’s release of a study published in JAMA, questioning the US Food and Drug Administration’s Accelerated Approval pathway. 16 August 2017
Pharmaceutical
Questions about the US Food and Drug Administration’s Accelerated Approval pathway are revealed today (August 15) in a study published in the Journal of the American Medical Association (JAMA). 15 August 2017
Pharmaceutical
In late June this year, the US Food and Drug Administration’s Commissioner Scott Gottlieb, issued a statement on the Drug Quality and Security Act (DQSA). The FDA’s commitment to upholding and following through on moves to protect the public from poorly compounded drugs shows that the Administration means business. 1 August 2017
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze