How to Survive a Multi-Year Consent Decree
Operating a business under a Consent Decree is extremely difficult; there is no area of the business that goes unaffected. In addition to fines that could reach $500 million, a three to five-year...
FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
FDA Approves Nasal Spray to Treat Depression in Adults
Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray. The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of...
FDA Approves First Therapy for Rare Blood-Clotting Disorder
On Wednesday, February 6th, FDA approved the Cablivi®(caplacizumab-yhdp) injection, the first product approved in combination with plasma exchange and immunosuppression specifically for adults with...
FDA Issues Draft Guidance to Advance Development of Combination Products
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...
FDA Issues Draft Guidance for Marketing Status Notifications
On Wednesday, January 30th, FDA issued a draft guidance which clarifies what information must be shared with the Agency regarding the marketing status of branded and generic drugs. The draft...
Rare Disease Drug Development: FDA Revises Draft Guidance Regarding Common Issues Sponsors Face During Orphan Drug Development
On January 16th, FDA issued a revised draft guidance outlining a number of common issues and challenges that many Sponsors face during the process of developing an orphan product. Though the...
FDA Draft Guidance on Tentatively Approved ANDA Submissions
FDA Draft Guidance on Tentatively Approved ANDA Submissions: On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22,...
FDA Takes Big Steps to Advance its Biosimilar Policy Framework
On Tuesday, December 11th, FDA made large strides to advance its biosimilar policy framework, including the release of four guidance documents and a proposed rule. Through these guidance documents,...
