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Real-World Data/Evidence Submission Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Submitting Documents Using Real-World Data and Real-World E...

RWD, RWE Submission Guidance

[ Price : $8.95]

FDA publishes a final guidance on identifying real-world data and real-world evidence submitted in INDs, NDAs, and BLAs.

FDA Denies 2014 LASIK Petition

[ Price : $8.95]

FDA denies a petition seeking a Boxed Warning for excimer lasers used in LASIK procedures.

At-home AI Skin Cancer Screener Being Studied

[ Price : $8.95]

Sklip Inc. receives IRB approval to clinically test its Sklip artificial intelligence skin cancer triage system with patients in h...

Orilissa Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Neurocrine Biosciences Oril...

OTC Drug Labeling Information Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled General Drug Labeling Provisions and OT...

UCS Surveying State of Science Under Biden

[ Price : $8.95]

The Union of Concerned Scientists says it will be asking scientists in seven federal agencies to describe the state of science in ...

FDA Breast Implant Cancer Alert

[ Price : $8.95]

FDA says its monitoring of breast implants has detected some cases of squamous cell carcinoma and various lymphomas in the scar ti...

FDA Emergency Monkeypox Test Guidance

[ Price : $8.95]

FDA publishes an immediately effective guidance on emergency use authorizations for monkeypox diagnostic tests.

Panacea Biotec Inspection is OAI

[ Price : $8.95]

Indias Panacea Biotec says it is working with FDA to close a recent inspection that had eight observations and an Official Action ...