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USA – FDA issues draft guidance on communications with combo product developers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