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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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Speaking at the annual get-together of the Food and Drug Law Institute, US Food and Drug Commissioner Scott Gottlieb suggested on Thursday that the federal law on kickbacks could be applied in order to lower prescription drug prices. 4 May 2018
Generics
In a statement to the US Senate appropriations committee, Food and Drug Administration Commissioner Scott Gottlieb reiterated his goal of “modernizing generic drug development and review,” with the aim of boosting competition in the sector and increasing rates of generic substitution, ultimately in order to lower drug costs. 25 April 2018
Pharmaceutical
In the wake f the ongoing opioid crisis in the USA, the Food and Drug Administration on Friday announced the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). 23 April 2018
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has welcomed the White House budget request of $5.8 billion for the agency in 2019, an increase of 13% from this year. 18 April 2018
Biosimilars
During the recent National Health Policy Conference run by America’s Health Insurance Plans, the US Food and Drug Administration’s Commissioner Dr Scott Gottlieb shared his candid remarks on the state of the pharmaceutical market in the USA.1 While drug prices are traditionally not part of the FDA’s responsibilities, the physician and cancer survivor was passionate about highlighting his observations of the American healthcare industry, says Dr Nicola Davies in her monthly exclusive blog for The Pharma Letter. 12 April 2018
Pharmaceutical
The US Food and Drug Administration has proposed a number of research studies with the aim of supplying scientific backing for its policies related to marketing of prescription drugs. 13 March 2018
Pharmaceutical
A review published in JAMA Oncology has shown the overall success of the US Food and Drug Administration’s (FDA) accelerated approval (AA) program for getting promising cancer drugs to patients faster. 6 March 2018
Pharmaceutical
As Rare Disease Day approaches, the US FDA has released a statement outlining steps the agency is taking to promote the development of therapies in this area. 27 February 2018
Pharmaceutical
With the USA’s flu epidemic apparently subsiding, the FDA’s Commissioner Scott Gottlieb has provided an update on his agency's efforts to improve the effectiveness of influenza vaccines. 27 February 2018
Pharmaceutical
Research published in the European Journal of Clinical Pharmacology has shown that the US Food and Drug Administration consistently beats other agencies to the finishing line in approving new drugs. 26 February 2018
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