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Sponsors may not have to conduct new efficacy trials for the anti-opioid treatment buprenorphine injections or implants if there are existing data for similar products under a final guidance issued Wednesday. Read More
High drug prices cannot solely be laid at the feet of drug manufacturers, said Peter B. Bach, a director at the Memorial Sloan Kettering Cancer Center. Read More
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