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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
The Purple Book—a database containing information about all licensed biological productsis set for a revamping that offers more patent transparency regarding reference biologics.
Our FDA lawyers discuss provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act that are of particular concern and interest for the pharmaceutical, medical device, animal drug, and food industries, as well the potential effects of the stimulus package, in this recent LawFlash.
US President Donald Trump signed a pair of appropriations bills into law on December 20, including bipartisan legislation intended to facilitate the development of generic and biosimilar products.
A handful of bills that comprised a healthcare reform package championed by Florida House Republicans are on their way to the governor’s desk where they’ll likely be signed into law.
The New York State Drug Take Back Act (Act), which was signed into law on July 10, 2018, went into effect on January 6, 2019.

The proposed Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 could become law in the near future as the Congressional Budget Office reported that the legislation would not increase the budget deficit. The proposed bill would change the oversight of the commercial marketing of OTC drugs by the FDA and authorize the collection and spending of user fees to cover the cost of expediting FDA’s administrative procedures related to OTC products. Both the Senate and the House have proposed versions of the bill that are largely similar with variances mostly in the length of exclusivity. Therefore, manufacturers can reasonably rely on the major provisions of the bill that are not likely to change.  Manufacturers can start preparing for the proposed revisions by organizing their current OTC product portfolios according to the ingredients’ current monograph status and identifying any ingredients that may be at risk for more immediate FDA action that could impact their regulatory marketing status.