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)…
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…
“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…
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…
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. Source:…
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,…
FDA’s Real-Time Oncology Review (RTOR) program shaved about two months off the average approval time for cancer therapeutics Genentech has submitted through the program, said Grace Gao, regulatory affairs program…
The FDA issued a 10-observation Form 483 to Omega & Delta’s manufacturing facility in Carolina, Puerto Rico, following an April 25 to May 6 inspection that unearthed an inadequate water…
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…
A New York district judge has once again thrown out a whistleblower complaint alleging that Novartis offered doctors kickbacks to entice them to prescribe its multiple sclerosis blockbuster Gilenya (fingolimod).…