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Leaders of the Senate Finance Committee invited seven leading drug companies to testify in an upcoming hearing on drug pricing — and hinted that they will take a more aggressive approach if the drugmakers decline the invitation. Read More
The Association for Accessible Medicines is sounding the alarm on a House bill that would alter 180-day exclusivity for generics to allow for faster market entry of competitors. Read More
The European Medicines Agency began a six-month public consultation Thursday for draft principles on a common EU standard for human drug electronic product information. Read More
FDA Commissioner Scott Gottlieb announced that the agency has developed easy-to-understand model drug facts labels (DFLs) to encourage drugmakers to develop an OTC version of the opioid overdose treatment naloxone. Read More
The FDA released two draft guidances outlining the agency’s latest thinking on assessments of risk evaluation and mitigation strategy (REMS) programs. Read More
The FDA announced that the impurities found in valsartan-containing blood pressure drugs may have been caused by specific chemicals and reaction conditions in the manufacturing process of the drug’s API. Read More
The FDA reopened on January 25 following a 35-day partial shutdown of the federal government that curtailed the agency’s inspection activities that did not directly tie into public safety. Read More
CDER released its latest annual report on drug safety priorities, detailing how it approached drug safety in 2018 — including how it handled the valsartan impurity crisis. Read More