Clinical Research Solutions
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...
Clinical Research Solutions
FDA Issues Draft Guidance to Advance Development of Combination Products
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...
Clinical Research Solutions
FDA Issues Draft Guidance for Marketing Status Notifications
On Wednesday, January 30th, FDA issued a draft guidance which clarifies what information must be shared with the Agency regarding the marketing status of branded and generic drugs.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...
Clinical Research Solutions
Rare Disease Drug Development: FDA Revises Draft Guidance Regarding Common Issues Sponsors Face During Orphan Drug Development
On January 16th, FDA issued a revised draft guidance outlining a number of common issues and challenges that many Sponsors face during the process of developing an orphan product.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...
Clinical Research Solutions
FDA Draft Guidance on Tentatively Approved ANDA Submissions
FDA Draft Guidance on Tentatively Approved ANDA Submissions: On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22,...
Regulatory Sciences
FDA Advances 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,...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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,...