FDA Releases New Enforcement Policy for OTC Sunscreen Drug Products Marketed Without an Approved Application

FDA Releases New Enforcement Policy for OTC Sunscreen Drug Products Marketed Without an Approved Application

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FDA Updates Guidance on User Fee Waivers, Reductions and Refunds

FDA Updates Guidance on User Fee Waivers, Reductions and Refunds

Posted 20 June 2018 | By Michael Mezher  The US Food and Drug Administration (FDA) on Wednesday issued a revised draft guidance providing recommendations to drugmakers planning to request a waiver or reduction in user fees for drugs and biologics.    The draft guidance updates the agency’s 2011 final guidance User Fee Waivers, Reductions and Refunds for Drug and […]

Major Depressive Disorder: FDA Updates 40-Year-Old Guidance

Major Depressive Disorder: FDA Updates 40-Year-Old Guidance

The US Food and Drug Administration (FDA) is revising its guidance on the clinical development of treatments for major depressive disorder (MDD).    FDA says the guidance—being issued today in draft form—contains major revisions to its 1977 Guidelines for the Clinical Evaluation of Antidepressant Drugs.    The recommendations made in the eight-page guidance apply to monotherapeutic, combination […]

Cassidy requests FDA take action to address nationwide drug shortages

Cassidy requests FDA take action to address nationwide drug shortages

WASHINGTON, D.C. (Senator Bill Cassidy) – U.S. Senators Bill Cassidy and Chris Murphy, both members of the Senate Health, Education, Labor, and Pensions Committee, led a bipartisan group of Senators in requesting assistance from the Food and Drug Administration (FDA) to address the ongoing drug shortage crisis across the United States. The senators requested that […]

FDA Could Approve First Prescription Drug Made From Marijuana Plant

FDA Could Approve First Prescription Drug Made From Marijuana Plant

Follow CBSPHILLY Facebook Twitter PHILADELPHIA (CBS) — The first prescription drug made from the marijuana plant could soon be approved by the FDA. Regulators are expected to issue a decision by the end of June on the drug epidiolex. It would be used to treat epilepsy in kids. Frito-Lay Introduces Dinosaur-sized Dorito  The drug is a purified […]

FDA Hits Valeant's Plaque Psoriasis Drug with a Complete Response Letter

FDA Hits Valeant's Plaque Psoriasis Drug with a Complete Response Letter

Ortho Dermatologics, a division of Quebec-based Valeant Pharmaceuticals International, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Duobrii for plaque psoriasis. Duobrii is a combination of halobetasol propionate and tazarotene, which when used separately to treat plaque psoriasis, can only be used for […]

BRIEF-FDA Allows Label For Novartis' Drug Cosentyx To Include Psoriatic Arthritis Benefit

BRIEF-FDA Allows Label For Novartis' Drug Cosentyx To Include Psoriatic Arthritis Benefit

June 19 (Reuters) – Novartis AG: * NOVARTIS RECEIVES FDA APPROVAL FOR INCLUSION OF NEW EVIDENCE THAT COSENTYX® INHIBITS PROGRESSION OF JOINT STRUCTURAL DAMAGE IN PSORIATIC ARTHRITIS * NOVARTIS – RECEIVES FDA APPROVAL FOR INCLUSION OF NEW EVIDENCE THAT COSENTYX INHIBITS PROGRESSION OF JOINT STRUCTURAL DAMAGE IN PSORIATIC ARTHRITIS * NOVARTIS-NEW PRESCRIBING INFORMATION TO INCLUDE […]