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The FDA issued a draft and separate final guidance dealing with when the agency would exercise enforcement discretion for certain violations covering repackaging products. The draft addresses biologics, while the final guidance deals with drugs. Read More
Regeneron Pharmaceuticals received a subpoena last month as part of a Department of Justice investigation into the nonprofit organizations that play a key role in reducing the sticker price of some drugs. Read More
Sen. Chuck Grassley (R-Iowa) is planning to examine the FDA’s orphan drug programs to find out if companies are using the designation to justify higher prices for common drugs. Read More
Tom Price was confirmed by the Senate as the next Secretary of HHS in a late-night Thursday vote and swiftly sworn in Friday morning by Vice President Mike Pence. Read More
The International Council on Harmonization is proposing to expand guidance concerning data quality, medication errors and product issues by developing a more detailed companion document that would include Q&A sections and more examples. Read More
A group of 31 Democratic senators have asked Kaléo to provide details on pricing of the company’s opioid overdose treatment Evzio, requesting documents on production costs and donation programs. Read More
FDA medical officers — including those involved with product review and post-market safety monitoring across CDER, CBER and CDRH — will be exempt from the federal hiring freeze, according to an HHS memo. Read More