Blog

On March 31, the Federal District Court in Maryland upheld the Centers for Medicare & Medicaid Services’ (CMS) “new formulation” definition. CMS issued the new definition in its November 2021 final rule under the Medicaid Drug Rebate Program (MDRP), taking effect January 1,...

Over the past few years, FDA has lobbied to tighten (or even eliminate) the 180-day exclusivity period currently granted to the first generic drug applicant that submits an ANDA seeking FDA approval for a generic based on a listed drug product.
This exclusivity period provides an incentive...

On September 30, 2021, a Washington D.C. circuit appellate court ruled that FDA violated the Orphan Drug Act and unlawfully infringed on Catalyst Pharmaceuticals Inc.’s orphan drug exclusivity period when it approved another company’s drug - the same drug to be used in treating the same...

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...

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...

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 While the LPAD Pathway final guidance is largely unchanged from the June 2018 draft guidance, FDA has added some important content to help clarify information...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 This update to the 2016 draft guidance offers FDA recommendations on the content and timing of pediatric study plan submissions, and the content and timing of requested...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...