The bill was initially introduced in June 2016 by members of the Senate Judiciary Committee, and was reintroduced in the Senate and House of Representatives last week. The revived version of the bill focuses on sample sharing as well as shared safety protocols.
If signed into law, the CREATES Act would allow generic manufactures to bring an action in federal court to obtain the samples that are needed in generic drug development. Additionally, the bill would also authorize judges to award damages to the generic companies to avoid any delays from occurring in the future.
FDA Warns OTC Manufacturer After Finding Inaccurate Information in Product Listings
On Thursday, June 1st, the FDA issued a Warning Letter to Prestige Brands Holdings, an over-the-counter (OTC) drug manufacturer. PediaCare Children’s Plus Multi-Symptom Cold and PediaCare Children’s...