Regulatory

Mar 10, 2016
Elvis Pacelat asks why the prospect of harmonized content is so challenging, and what can pharma companies learn from other sectors about more optimal, modern ways of working and sharing data?
Mar 03, 2016
Clinical trials are challenging because pain is subjective, making it hard to define objective endpoints or to compare one drug to another.
Mar 03, 2016
More generics and biosimilars may generate competition — but FDA opposes broad compounding, writes Jill Wechsler.
Mar 02, 2016
Various factors have altered the landscape for exchange of information on drugs and medical products, but the FDA has not kept pace in updating its rules governing what marketers can say about their therapies, writes Jill Wechsler.
Feb 26, 2016
FDA needs to make major changes in how it evaluates R&D of new combination therapies for cancer and other serious conditions, say patient advocates, cancer specialists and biopharma companies.
Feb 25, 2016
After eight years in development, FDA is looking to expand its Sentinel system to play a more visible role in assessing medical product efficacy, as well as safety.
Feb 18, 2016
Arvind Mani and Sherry O' Quinn outline the prevalence of private payer PLAs in Canada.
Feb 11, 2016
There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.
Feb 04, 2016
Valeant and Turing's fuzzy explanations of pricing practices to the House Oversight and Government Reform Committee cast a shadow over the broader industry, writes Jill Wechsler.
Feb 01, 2016
GOP critics of the Agency are planning more oversight of regulatory programs and policies. Jill Wechsler reports.
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