The CDER and CBER call a prospective written plan to assess and manage post-approval chemistry, manufacturing, and controls (CMC) changes a Comparability Protocol (CP). These protocols are typically submitted in the original market application and, if the CP is approved, it allows firms to make certain changes outlined in the protocol without further FDA approval. […]
On October 1, 2026, the “FDA approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease”. What makes this implantable heart valve device so special is that it can be adjusted in size as the child grows and, as a result, potentially eliminates the need for […]
The Medical Device User Fees have been announced for FY2027. The Federal Register (FR) Notice can be found here: MDUFA FY2027. See the Lachman Blog for additional user fee blogs: GDUFA, BSUFA, PDUFA, ADUFA/AGDUFA, and Outsourcing. In addition to the inflation adjustment, which is always expected, further adjustments were required to meet the inflation adjusted […]
The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]
In a June 25, 2026 notice on data integrity in medical devices, the FDA takes note of “an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical […]
Over the last six to eight months, the FDA’s activity regarding compliance with the required posting of ongoing and completed clinical trials has significantly increased, as evidenced by the issuance of multiple warning letters and letters of non-compliance to sponsors and/or principal investigators. To assist responsible parties in complying with the requirement to post on […]
On June 16, 2026, the FDA issued a letter to healthcare providers (here) indicating that it “is aware that the U.S. is experiencing interruptions in the supply of stereotactic breast biopsy needles because of recent supplier issues.” The FDA expects the disruption in supply and the resultant shortage to be short term, with likely resolution in […]
