Boehringer Ingelheim suggested the FDA draft guidance on child resistant packaging labeling, published in August, could confuse consumers who may not understand why only some drug products bear the CRP…
The FDA has formalized its guidelines for sponsors seeking reconsideration of scientific or regulatory issues early in the approval process for generic drugs, issuing a guidance that also affirms the…
The FDA has revised its draft guidance on content and formatting for Risk Evaluation and Mitigation Strategy documents to highlight who is responsible for each required action, rather than just…
Healthcare providers strongly endorsed the 340B program that supplies them with drugs at discount, telling members of a House committee that it’s essential for supporting outreach to underserved communities. Source:…
RARITAN, N.J., Oct. 11, 2017 /PRNewswire/ --Janssen Research & Development, LLC (Janssen) today announced that it has established the Integrated Smart Trial & Engagement Platform (iSTEP), a first-of-its-kind information technology…
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-astrazeneca-pascal-soriot.jpg" NAME"Why AstraZeneca PLC CEO Took a Job His Friends Called a Suicide Mission" ALT"Why AstraZeneca PLC CEO Took a Job His Friends Called a Suicide Mission"October 11, 2017By…
Avita Medical A$16.9 Million Capital RaisingVALENCIA, Calif. & PERTH, Australia & LONDON--(BUSINESS WIRE)--Avita Medical (ASX: <a target"_blank" href"http://cts.businesswire.com/ct/CT?idsmartlink&urlhttp%3A%2F%2Fwww.asx.com.au%2Fasx%2Fshare-price-research%2Fcompany%2FAVH&esheet516... Source: BioSpace
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x430-flexion-mike-clayman.jpg" NAME"Flexion Eyes Creation of 100 New Sales Jobs to Sell Just-Approved Osteoarthritis Drug" ALT"Flexion Eyes Creation of 100 New Sales Jobs to Sell Just-Approved Osteoarthritis Drug"October 11, 2017By…
BURLINGTON, Mass., Oct. 11, 2017 /PRNewswire/ --MilliporeSigma today officially opened its new Life Science Center in Burlington, Massachusetts. The new center serves as a regional hub for scientific advancement and…
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-deal3.jpg" NAME"Lupin Coughs Up $150 Million Cash for This New Jersey-Based Biopharma" ALT"Lupin Coughs Up $150 Million Cash for This New Jersey-Based Biopharma"October 11, 2017By Alex Keown, BioSpace.com Breaking…