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Drugmakers would be required to revise product labels to reflect new health risk information, including updates on pediatric warnings, and conduct additional tests when issues arise around at-risk populations, under legislation introduced Dec. 6 by Canada’s health minister. Read More
Drugmakers are pushing back against an Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration to allow authorized persons without access to the complete marketing application to release batches of a drug. Read More
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