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CDER and CBER published agendas of draft guidances planned for the 2017 calendar year, covering required pediatric study compliance and pediatric oncology development, recommendations for adaptive clinical trial designs, and the development of standards used in biologics submissions. Read More
Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics and pharmacodynamics. Read More
Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to quality management issues. Read More
The Office of Management and Budget clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over $100 million per year, and new guidance documents considered on a case-by-case basis. Read More
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