FDA News


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On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS Act).  According to a recent statement from Scott Gottlieb, MD, FDA Commissioner, the Agency no longer has intentions to modify the proper names of biological products […] READ MORE...


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 depression in adults suffering from treatment-resistant depression. In a recent statement, Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the […] READ MORE...


Draft Guidance: Requesting Nonbinding Feedback After an FDA Inspection of Your Medical Device Establishment

On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted during pre or postmarket inspections. Nonbinding Feedback In its draft guidance, FDA states that the intention of nonbinding feedback is to inform a Sponsor’s implementation […] READ MORE...


FDA Warns Health Care Providers About the Development of Cancer After Breast Implants

On Wednesday, February 6th, FDA issued a letter to health care providers to increase the awareness of an association between all breast implants and Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL). Reports received by the FDA indicate that patients with breast implants have a higher risk of developing the disease within the scar capsule adjacent […] READ MORE...


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 acquired thrombotic thrombocytopenic purpura (aTTP). What is aTTP? aTTP is the development of extensive blood clots in the small blood vessels throughout the body of a patient. These clots can cut […] READ MORE...


FDA Issues Draft Guidance to Advance Development of Combination Products

On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. These submissions include new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for drug-led combination products; stand-alone or biosimilar biologics license applications (BLAs) for biologic-led […] READ MORE...


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 guidance, entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format,” will assist Sponsors of new drug […] READ MORE...


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 regulatory requirements and approval process is the same for both common and rare diseases, there is often limited medical and scientific knowledge, natural history […] READ MORE...


FDA Issues 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, 2018.  The draft guidance, entitled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs,” is intended to assist Sponsors in preparing and submitting amendments to tentatively approved abbreviated new drug […] READ MORE...


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, FDA intends to maintain efficient regulatory processes for innovative and generic drug products. The first draft and final guidance documents provide “greater clarity on scientific and […] READ MORE...