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Human Drugs

Akorn Gains Approval for OTC Generic Flonase

FDA approves an Akorn ANDA for an over-the-counter version of GlaxoSmithKlines Flonase (fluticasone propionate) nasal spray USP, 50 mcg per spray, ind...

FDA General

Dietary Supplement Ingredients to Avoid Listing Launched

FDA launches a new tool to alert the public when it becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements the onl...

Federal Register

Info Collection Extension for Expanded Access Requests

Federal Register notice: FDA submits to OMB an information collection extension for its Guidance for Industry on Individual Patient Expanded Access Ap...

Human Drugs

Workshop on Drug Analysis Data Standards Advancement

Federal Register notice: FDA announces a 6/12 public workshop entitled Advancing the Development and Implementation of Analysis Data Standards: Key Ch...

Human Drugs

No Benefit in Taking Supplements: NIH Study

NIH director Francis Collins says a study found that dietary supplements do not extend life for most people in the general population.

Biologics

FDA Approved 2 Gene Therapies, 3 Vaccines in 2018: CBER

CBER director Peter Marks posts an FY 2018 annual report highlighting Center accomplishments including approval of two gene therapies and three vaccin...

Human Drugs

Too Many Cancer Immunotherapeutics Available?

FDA Oncology Center of Excellence director Richard Pazdur quizzes cancer immunotherapeutics makers on whether there are too many of their products on ...

Medical Devices

Breakthrough Status for Preeclampsia Targeted Apheresis

FDA grants Advanced Prenatal Therapeutics a breakthrough device designation for its Targeted Apheresis Column for Preeclampsia.

Human Drugs

Intensity Therapeutics Fast Track for Breast Cancer Therapy

FDA grants Intensity Therapeutics a fast track designation for INT230-6 and its use in treating patients with relapsed or metastatic triple negative b...

Human Drugs

FDA Withdraws Approval of 31 ANDAs

Federal Register notice: FDA announces the withdrawal of 31 ANDAs from multiple applicants because they are no longer marketed.