Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.

The draft Medicare physician fee schedule (MPFS) for 2026 proposed to treat skin substitutes as incident-to supplies in the related procedures, but the blowback was pronounced and vigorous, with London-based Convatec plc arguing that the agency lacks the statutory authority to make such a change.

The first phase of the EU’s Data Act is now officially in place, although member state enforcement of the Act might be spotty. This is because several nations, including Germany, have yet to finalize implementing regulations for the Data Act, a problem these nations will have to fix as the secondary and tertiary compliance dates arrive in August 2026 and August 2027.

The American Medical Association has posted the latest update to the current procedural terminology code set, which deletes more than 80 existing codes and adds nearly 290 new codes. Among the new codes are several for AI-assisted device services and several tweaks to codes for peripheral artery diseases, presenting a new batch of opportunities for device makers to obtain Medicare coverage for their offerings.

Health Canada posted a report on reduction of red tape, which includes a proposal for mutual recognition of other regulators’ inspections of device and drug manufacturing facilities.

It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.

Physician ownership of medical device manufacturers can be tricky stuff where the Anti-Kickback Statute is concerned, but the Office of Inspector General recently declared it had no problem with one such arrangement due to the physician’s ratio of ownership of the company.

The U.S. Government Accountability Office said in a recent report that the Medicare national coverage determination process could use a few adjustments, but the report also pointed to significant resource problems associated with the process, a source of drag that only Congress can fix.

Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts.

Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.