FDA Related News

Human Drugs

3-Year New Clinical Investigation Exclusivity Guidance Explained

Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.

FDA General

Senate Committee Postpones FDA Funding Bill Consideration

Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republican reconciliation ...

Human Drugs

Repeat Medline CGMP Violations Cited

FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.

Human Drugs

CGMP Violations at Laboratorios Jaloma

FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.

Manufacturer Economic Info Communications Q&A Guidance

FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.

Human Drugs

ICH Finalizes Guide on Model-Informed Drug Development

FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computational modeling and simul...

Human Drugs

Guide on Using Prior Knowledge for Genome Editing Gene Therapies

FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to s...

FDA Challenged to Keep Up With ALS Therapies

Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace with changes in cont...

Human Drugs

Drop Rabbit Pyrogen Test References: Petition

Animal Defenders International petitions FDA to remove all references to rabbit pyrogen testing from its regulations and permit the use of validated n...

Biologics

FDA Orders Takeda to Add Boxed Warning to Adzynma

FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition of a Boxed Warning, a...