Changes to the Regulatory Landscape, and what they mean.

FDA Sets a July 30 Panel on Replimune’s Melanoma Drug

FDA’s advisory committee for cell, tissue, and gene therapies will meet on 30 July to weigh Replimune’s vusolimogene oderparepvec for advanced melanoma. The meeting is virtual, the docket closes 29 July, and the deadline to reach the committee is sooner than that.

By Connor Griggs17 July 20265 min read

FDA

FDA Can Now Ask the Public for OTC Monograph Data

A one-page notice in Thursday’s Federal Register explains how FDA will formally ask the public for data to inform changes to over-the-counter drug monographs. It reads like plumbing. It is also a lever the agency can now pull on its own initiative.

17 July 20265 min read

Guidance

FDA Retires a 1995 Guidance on Topical Steroids

The vasoconstrictor test that decides whether a generic hydrocortisone cream is equivalent to the brand had been governed, on paper, by a document from the Clinton administration. FDA finally replaced it — and, unusually, said what moved.

17 July 20265 min read

Devices

MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock

The draft commitment letter for FY 2028–2032 would ramp the 510(k) shared outcome goal down to 112 days, charge a fee for Pre-Submissions, and invent a 45-day follow-up meeting type. The public gets its say on 5 August — and thirty days to write it down.

16 July 20266 min read

FDA

FDA Sets a September Hearing on Psychedelic Therapy

The same Federal Register issue that finalised the psychedelic trial guidance also scheduled a part 15 hearing on what comes after approval — training, safety, access, and data. The notice is equally precise about the five things it will not discuss.

16 July 20265 min read

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Showing 9 of 9 stories

A scientist at FDA's Center for Biologics Evaluation and Research examining a cell-culture flask under an inverted microscope

FDA FDA Sets a July 30 Panel on Replimune's Melanoma Drug Jul 17, 20265 min read Read the story

Buildings 1 and 21 at the entrance to the FDA's White Oak campus, with the Maryland and agency flags flying

FDA FDA Can Now Ask the Public for OTC Monograph Data Jul 17, 20265 min read Read the story

Gloved hands loading sample tubes into a benchtop centrifuge in an FDA laboratory

Guidance FDA Retires a 1995 Guidance on Topical Steroids Jul 17, 20265 min read Read the story

FDA Building 66, home of the Center for Devices and Radiological Health

Devices MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock Jul 16, 20266 min read Read the story

Rows of empty seats facing an FDA-branded screen in the White Oak Great Room

FDA FDA Sets a September Hearing on Psychedelic Therapy Jul 16, 20265 min read Read the story

A scientist working at a cabinet in an FDA laboratory

FDA FDA Would Let Distributed Manufacturers Register Once Jul 16, 20266 min read Read the story

A gloved hand holding a tablet over dissolution-testing equipment in an FDA laboratory

Guidance FDA's OTC Monograph Meetings Guidance Is Final Jul 16, 20265 min read Read the story

The Food and Drug Administration sign above the entrance to the agency's headquarters

FDA FDA's Psychedelics Guidance Is Final, After Three Years Jul 15, 20265 min read Read the story

The hemicycle of the European Parliament in Brussels

EU MDR & IVDR EUDAMED's Next Deadline Is Narrower Than It Looks Jul 15, 20266 min read Read the story

Top Stories

FDA Sets a July 30 Panel on Replimune’s Melanoma Drug

FDA Can Now Ask the Public for OTC Monograph Data

FDA Retires a 1995 Guidance on Topical Steroids

MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock

FDA Sets a September Hearing on Psychedelic Therapy

FDA

FDA Can Now Ask the Public for OTC Monograph Data

FDA Retires a 1995 Guidance on Topical Steroids

MDUFA VI: The Draft Deal Is Out, With a Faster 510(k) Clock

FDA Sets a September Hearing on Psychedelic Therapy

FDA Would Let Distributed Manufacturers Register Once

Guidance

FDA Can Now Ask the Public for OTC Monograph Data

FDA Retires a 1995 Guidance on Topical Steroids

FDA’s OTC Monograph Meetings Guidance Is Final

FDA’s Psychedelics Guidance Is Final, After Three Years

Clinical

FDA Retires a 1995 Guidance on Topical Steroids

FDA Sets a September Hearing on Psychedelic Therapy

FDA’s Psychedelics Guidance Is Final, After Three Years

Every story, searchable.

Every story, searchable.

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