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Clarifying how government- and sponsor-paid experts can sometimes aid sponsors in meetings with FDA, the agency updated its Manual of Policies and Procedures (MAPP) concerning special government employees (SGEs) who represent sponsors before the agency’s Center for Drug Evaluation and Research (CDER). Read More
Novartis released a statement Thursday saying it was the target of a dawn raid by the Swiss Competition Commission (COMCO) regarding misuse of a patent for a dermatology drug. Read More
“Quiet quitting” is not for everyone. Nearly 20 percent of regulatory affairs professionals switched jobs in 2021 seeking better pay, work/life balance, and a more diverse workplace, according to the Global Compensation and Scope of Practice Survey, conducted by the Regulatory Affairs Professionals Society (RAPS) and released during the group’s annual meeting in Phoenix earlier this week. Read More
In a pair of new reports, nonprofit research group the Institute for Clinical and Economic Review (ICER) assessed the cost benefit analyses for oral therapies treating amyotrophic lateral sclerosis (ALS) and gene therapies for use against hemophilia. Read More
The FDA and National Institutes of Health (NIH) have launched a public-private partnership to advance the research and development of a range of rare neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS). Read More
In publishing Q3D(R2) – Guideline for Elemental Impurities, the FDA has taken another step towards endorsing International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, this time focusing on catalysts and environmental contaminants that may be present in drug substances, excipients or drug products. Read More
After getting fewer than 50 comments on the proposed rule, the FDA has issued its final rule on the annual report pharmaceutical companies must submit on drugs they supplied under the Right to Try Act, a law that allows patients with life-threatening conditions access to certain unapproved investigational drugs and biological products. Read More