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Therapiva Private, an active pharmaceutical ingredient manufacturer in India, was hit with a Form 483 by the FDA for quality control unit and cleaning lapses. Read More
The World Health Organization (WHO) and international regulators including the FDA have launched a pilot program for joint GMP inspections of sterile drug manufacturers. Read More
Health insurers filed a class action suit against Gilead in a Florida federal court accusing it of anticompetitive behavior over its HIV treatments. Read More
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee split yesterday in a 6-6 vote over Durect’s Posirim (bupivacaine extended-release solution) for post-surgical analgesia. Read More
Opioid distribution data recently released by the Drug Enforcement Agency (DEA) shows an additional 24 billion opioid pills were distributed in the U.S. between 2013 and 2014 than was previously known. Read More
The Senate voted 89-10 yesterday to pass the United States-Mexico-Canada trade agreement, sending it to the president’s desk as generic and biologic drug advocates cheered the removal of a 10-year biologic exclusivity provision. Read More