Blog

On August 5, FDA issued its final guidance on the limited population pathway for antibacterial and antifungal drug approval (LPAD Pathway). While the LPAD Pathway final guidance is largely unchanged from the June 2018 draft guidance, FDA has added some important content to help clarify information...

As of March 23, 2020, around 90 biological products approved by Federal Food, Drug, and Cosmetic Act (FD&C Act) new drug applications shifted to deemed to be biological license applications under the Public Health Service Act. On February 20, FDA published its final rule changing the definition...

In July, FDA published its final guidance on how sponsors should prepare and submit an initial pediatric study plan (iPSP). This update to the 2016 draft guidance offers FDA recommendations on the content and timing of pediatric study plan submissions, and the content and timing of requested...

Long-anticipated revisions to the over-the-counter (OTC) monograph process have finally been enacted. President Trump signed the OTC monograph reform provisions into law on March 27, 2020 as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
Under the previous, nearly...

A recent FDA draft guidance significantly expands FDA authority regarding post-marketing studies -- in particular, the authority to require new efficacy studies and label modifications.
Until now, the FDA guidance on postmarketing studies and clinical trials has primarily focused on drug...

In examining the FDA’s clinical superiority hypothesis requirement for orphan drug designation, it’s helpful to consider the primary purpose of the Orphan Drug Act - to provide incentives for the development of promising orphan drugs that would not otherwise be developed and...

In most cases, the FDA grants orphan drugs a single seven-year exclusivity period for each designation covering a condition or disease. Once the seven years are up, drugmakers can apply for ANDA approval on generic versions of the drug - as long as they carve out any overlapping protected uses or...

Just two weeks after suffering defeat in U.K. patent battles involving pain drug Lyrica (pregabalin), pharma giant Pfizer has secured FDA Pediatric Exclusivity, extending their U.S. market exclusivity for Lyrica through June 30, 2019.
Pediatric Exclusivity is a powerful tool for drug...

One objective of the Hatch-Waxman Act was to help facilitate the approval and marketing of generic drugs while simultaneously guarding against patent infringement for the innovator product. Accordingly, the Hatch-Waxman Act requires ANDA applicants to make a certification regarding each of the...

Should the exclusivity of the original product protect biologics enhancements? That was one of several questions raised in a recent FDA hearing on Facilitating Price Competition and Innovation in the Biological Products Marketplace held September 4 at the Silver Spring, Maryland...