FDA Related News

Human Drugs

More Study of Patient-Reported Frailty Needed: FDA

CDER researchers say a five-item questionnaire they developed successfully used patient-reported data to evaluate frailty in multiple myeloma patients...

Human Drugs

SCOTUS Should Hear Label Highlights Appeal: PhRMA

PhRMA asks the Supreme Court to reverse an 11th Circuit Appeals Court decision that held Shire could unilaterally change the Highlights section of lab...

Medical Devices

FDA Enforcement Discretion Policy for Pandemic Tests

FDA develops a policy for the use of enforcement discretion for unauthorized tests in public health emergencies.

Human Drugs

FDA Stalls Xspray Pharmas Dasynoc

FDA issues a complete response letter for the Xspray Pharma Dasynoc NDA, asking for additional dosing information and information on a third-party man...

Biologics

Takeda Withdraws BLA for Dengue Vaccine

Takeda withdraws a BLA submission for its dengue vaccine candidate, TAK-003, after an FDA discussion on aspects of data collection, which cannot be ad...

Medical Devices

FDA Clears Avatar VR Surgical Planner

FDA clears the Avatar Medical virtual reality surgical planning solution.

Human Drugs

Cipla Recalls 6 Albuterol Sulfate Aerosol Batches

FDA says Cipla has recalled six batches of albuterol sulfate inhalation aerosols due to a container defect that could lead the inhaler to not deliver ...

Human Drugs

FDA Lifts Partial Hold on Curis Leukemia Trial

FDA lifts a partial clinical hold on the Curis Phase 1/2 trial of emavusertib in the TakeAim Leukemia study.

DTC Guidance May Signal Enforcement Shift: Attorneys

Three Hogan Lovells attorneys say a recently finalized FDA guidance on DTC drug promotion may signal an increase in promotion enforcement.