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...
The First FDA-approved Digital Pill - What It Means for Pharma

USA – The First FDA-approved Digital Pill – What It Means for Pharma

In mid-November 2017, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill...
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – Definition of the Term “Biological Product”

The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation that defines “biological product” to incorporate changes made by...
Proposed Legislation Targets a Critical Regulatory-Reimbursement Gap for Medical Devices

USA – NEJM Perspective: Congress Needs to Help FDA Combat Procedural Abuses

Congressional action is necessary stop pharmaceutical companies from abusing the Orphan Drug Act, filing sham citizen petitions and extending the market exclusivity for products that...

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