The release of ICH Q11 has been anticipated for some time now. The purpose of Q11 is to take the Quality by Design concepts mapped out in ICH Q8, Q9, and Q10 and apply them more clearly and specifically to the development and manufacture of drug substances (as opposed to...
Getting some good news for a change, Johnson & Johnson ranks fourth among all companies in Newsweek's annual Green Rankings, ahead of other pharmaceuticals that made the top 100, including: Baxter, BMS, Allergan, Pfizer, Abbott, Lilly, Merck, and Hospira.
Drug manufacturers have been coming to grips with how to leverage social media, from Tweets to blogs, without overstepping the bounds of compliance. Johnson & Johnson and a number of companies have taken the lead, as our Senior Editor for Digital Media Michele Vaccarello Wagner has written.
Just read Mina Kimes' enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's.
No one is tracking pharma's social media presence better than WhyDotPharma, and the site/blog has done a nice review of which pharma companies are Twittering the most (Amgen, Boehringer, JNJ, Genentech), and how they're doing it.
Paul D’Eramo—former ISPE chair, a two-decade veteran of FDA, and current head of Quality and Compliance Worldwide for Johnson & Johnson—always has a finger on the pulse of the regulatory environment, and knows that GMPs are fluid, not static.
The past few months have seen renewed vigor from FDA's DDMAC (Division of Drug Marketing, Advertising, and Communications) in scrutinizing manufacturers' claims of safety and efficacy. In particular, DDMAC has cracked down on makers and marketers of ADHD medications for their alleged false and misleading claims.