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China cleared the way for the U.S. Food and Drug Administration to add 10 new drug investigators to its local roster, following a Dec. 4 meeting between U.S. Vice President Joe Biden and Chinese President Xi Jinping. Read More
Under Brazil’s new antibribery law, prosecutors will be able to charge companies for bribery based on their actions outside that country. The “Clean Company Act,” as it is commonly known, takes effect in January. Read More
Still smarting from a 2012 parliamentary report lampooning India’s oversight of new drugs, the Ministry of Health is calling for accreditation of clinical trial sites and tougher regulation of clinical research. Read More
The European Medicines Agency may postpone a trial transparency initiative that was scheduled to take effect Jan. 1, 2014, due to an overwhelming number of comments from stakeholders. Read More
Drugmakers and the FDA have different ideas about the proper scale for the agency’s quality metrics program. While industry supports collecting data on no more than four metrics, the FDA promises only that it will monitor no more than 16. Read More
Merck Monday offered to pay out $27.7 million to settle nearly 1,200 personal injury lawsuits claiming its osteoporosis drug Fosamax caused jaw-bone deterioration known as osteonecrosis of the jaw (ONJ). Read More
A federal appeals court has raised the bar for whistleblowers filing False Claims Act (FCA) suits against drugmakers, saying they must provide specific information about the fraudulent claims made, not just broad allegations about a drugmaker’s conduct. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More
The FDA has handed Jubilant HollisterStier a warning letter for quality shortcomings at its Spokane, Wash., sterile drug manufacturing facility. Read More
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More
Lawmakers want the FDA to explain how hackers broke in to the CBER online submission system to steal personal user information and what the FDA has done to prevent a recurrence. Read More