FDA seeks ways to promote individualized therapies

USA – Atopic Dermatitis: FDA Finalizes Guidance on Timing of Pediatric Studies

The US Food and Drug Administration (FDA) finalized the 3-page guidance to help sponsors understand FDA’s current thinking about the relevant age groups to...
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

USA – FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be...
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance

USA – FDA issues draft guidance on communications with combo product developers

The 21st Century Cures Act requires FDA to provide final guidance on aspects of the submission process including how companies should obtain feedback from...
U.S. FDA Approves TherapeuticsMD's Menopause Drug

USA – U.S. FDA Approves TherapeuticsMD’s Menopause Drug

The U.S. Food and Drug Administration (FDA) approved TherapeuticsMD's oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats,...
FDA Drafts Guidance on Restricted Delivery Systems for Liquid Drugs

USA – FDA Finalizes Guidance on 503B Bulks List

Today, the US Food and Drug Administration (FDA) issued a final guidance for the drug compounding industry on the 503B Bulks List, which is...
FDA launches new resource to provide easily accessible, more accurate historical drug approval data

USA – FDA Looks to Speed Access to Potential COVID-19 Treatments

With the potential for a coronavirus vaccine likely more than a year away, the US Food and Drug Administration (FDA) is doing what it...
FDA Approves First Generic Drug to Receive CGT Designation

USA – FDA Approves First Generic Drug to Receive CGT Designation

The US Food and Drug Administration on Wednesday approved several versions of Apotex’s potassium chloride oral solution as the first generic drugs to receive...
FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

USA – Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages

The US Food and Drug Administration (FDA) is working to update its approach to drug shortages in the wake of Hurricane Maria in 2017 and other...
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

USA – CDER Drafts Drug Development Guidance on NASH With Compensated Cirrhosis

The Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) issued draft recommendations for sponsors looking to develop...
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance

USA – FDA updates COVID-19 compounding guidance with reporting clarification

Two guidance documents related to compounding drugs during the coronavirus pandemic were updated by the US Food and Drug Administration (FDA) on Thursday. Among...

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