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FDA Extends its Rare Pediatric Disease PRV Program 

FDA Extends its Rare Pediatric Disease PRV Program 

On December 27, 2020, FDA extended the Rare Pediatric Disease Priority Review Voucher Program as part of the Coronavirus Response and Relief Supplemental Consolidated Appropriations Act of 2021.
Originally set to expire in October 2020, renewal of the Rare Pediatric Disease Priority Review...

The Enduring Role of Orphan Drug Exclusivity for Biologics

The Enduring Role of Orphan Drug Exclusivity for Biologics

From Humira and Rituxan to Herceptin and Enbrel, biologics continue to succeed in tackling numerous, challenging diseases and conditions. Many new biologics receive Orphan Drug designation for treating rare diseases, meaning sponsors get 12 years of Reference Product Exclusivity and seven years of...

FDA Issues Final Guidance on LPAD Pathway 

FDA Issues Final Guidance on LPAD Pathway 

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 While the LPAD Pathway final guidance is largely unchanged from the June 2018 draft guidance, FDA has added some important content to help clarify information...

FDA Changes Definition of “Biological Product”

FDA Changes Definition of “Biological Product”

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...

New FDA Guidance Details How to Submit Pediatric Study Plans

New FDA Guidance Details How to Submit Pediatric Study Plans

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 This update to the 2016 draft guidance offers FDA recommendations on the content and timing of pediatric study plan submissions, and the content and timing of requested...

New Opportunity for OTC Product Market Exclusivity

New Opportunity for OTC Product Market Exclusivity

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...

Can the FDA Require Post-Market Efficacy Studies?

Can the FDA Require Post-Market Efficacy Studies?

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...



Benefits of FDA Pediatric Exclusivity

Benefits of FDA Pediatric Exclusivity

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...