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Following the destruction brought by Hurricane Maria in Puerto Rico, FDA Commissioner Scott Gottlieb said one of the agency’s main goals in the recovery effort is to bring the island’s medical product manufacturing plants back into operation. Read More
A federal judge in Nevada set a hearing for Oct. 17 on a move by BIO and PhRMA to block the state’s new law on price transparency for diabetes drugs, after rejecting their request to head off the law before it takes effect Oct 1. Read More
The Saint Regis Mohawk tribe asked a federal agency to dismiss several challenges of the patents it now holds for Allergan, arguing the tribe is a sovereign nation and immune to such challenges. Read More
The FDA sent Intellipharmaceutics a complete response letter for Rexista — an extended-release oxycodone tablet rejected in July by an FDA advisory committee — calling for additional studies of the drug’s abuse-deterrent properties. Read More
The FDA recently took action against more than 500 websites for illegally selling unapproved prescription medicines through the mail — including opioids, antibiotics and injectable epinephrine — as part of a broad international crackdown involving 115 countries. Read More
The FDA and the HHS Office of Human Research Protections finalized their joint guidance detailing requirements for keeping minutes of institutional review board meetings, as part of a push to harmonize research regulations across the government before 2020. Read More