FDA Targets Facilities in China, India
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data…
FDA Clarifies ICH Guideline on Drug Starting Materials
More than four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on starting materials for chemical entity drug substances. Source: Drug GMP…
Louisiana Company Ordered to Cease Operations for GMP Violations
Pick and Pay, also doing business as Cili Minerals, was ordered to cease operations by a federal district judge for GMP violations until it gets written permission from the FDA…
Pfizer’s Hospira Draws Warning Letter for Quality Defects
The FDA hit Pfizer’s Hospira for failing to fully investigate quality defects, such as the presence of cardboard, in batches of injections and neglecting to take corrective measures. Source: Drug…
<b>Bernie Sanders:</b> <b>Trump</b> Must Stop Sanofi's Exclusive Zika Deal
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-sanofi.jpg" NAME"Bernie Sanders: Trump Must Stop Sanofi's Exclusive Zika Deal" ALT"Bernie Sanders: Trump Must Stop Sanofi's Exclusive Zika Deal"March 14, 2017By Alex Keown, BioSpace.com Breaking News StaffWASHINGTON... Source: BioSpace
What a Gilead-Incyte Marriage Would Look Like
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-deal2.jpg" NAME"What a Gilead-Incyte Marriage Would Look Like" ALT"What a Gilead-Incyte Marriage Would Look Like"March 14, 2017By Alex Keown, BioSpace.com Breaking News StaffFOSTER City, Calif. As <A HREF... Source:…
3 Dazzling Biotechs Poised to Soar Even More
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks5.jpg" NAME"3 Dazzling Biotechs Poised to Soar Even More" ALT"3 Dazzling Biotechs Poised to Soar Even More"March 14, 2017By Mark Terry, BioSpace.com Breaking News StaffAlthough 2016 wasnt a huge…
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