FDA News


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FDA Issues Draft Guidance to Advance Development of Combination Products

On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate.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FDA Issues Draft Guidance for Marketing Status Notifications

On Wednesday, January 30th, FDA issued a draft guidance which clarifies what information must be shared with the Agency regarding the marketing status of branded and generic drugs.  The draft guidance, entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format,” will assist Sponsors of new drug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Rare Disease Drug Development: FDA Revises Draft Guidance Regarding Common Issues Sponsors Face During Orphan Drug Development

On January 16th, FDA issued a revised draft guidance outlining a number of common issues and challenges that many Sponsors face during the process of developing an orphan product.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FDA Draft Guidance on Tentatively Approved ANDA Submissions

On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22, 2018.  The draft guidance, entitled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs,” is intended to assist Sponsors in preparing and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...


FDA Proposes Changes to the De Novo Pathway

On Tuesday, December 4th, FDA published the De Novo Classification Proposed Rule. If finalized, the rule would establish procedures for the De Novo classification process by facilitating appropriate classification for new medical devices. The proposed rule provides structure, clarity, and transparency for the De Novo process.  It establishes rules for the submission and withdrawal of […] READ MORE...


FDA Announces Plans to Modernize its 510(k) Medical Device Approval Process

On Monday, November 26th, FDA announced changes to modernize the 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the “clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market – otherwise known as a predicate device.”  The changes will […] READ MORE...


FDA Takes Steps to Promote Digital Tools for Prescription Drugs

On Tuesday, November 20th, FDA announced the establishment of a public docket to solicit comments and feedback on a proposed framework regarding the regulation of prescription drug-use-related software applications. In a recent Federal Register notice, the Agency defines prescription drug-use-related software as “software disseminated by or on behalf of a drug sponsor that accompanies one […] READ MORE...


FDA to Modify Informed Consent Rules, Seeks Feedback

On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations, informed consent must be provided by subjects before participating in a trial. The only exceptions under current FDA regulation is if the subject is in a life threatening situation […] READ MORE...