USA – FDA reduces number of samples to retain for BA/BE testing

In a part-draft, part-final guidance issued on Tuesday, the US Food and Drug Administration (FDA) finalized its policy on the quantity of reserve samples...

USA – FDA offers guidance on observational studies as RWE

The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as...

USA – FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products

On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s...

USA – FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy

Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years...

USA – Industry clamors for clarity on FDA’s advanced manufacturing designation program

Industry is welcoming FDA’s upcoming advanced manufacturing technologies (AMT) program but is clamoring for more clarity on crucial details like what methods will be...

USA – FDA proposes rule for difficult-to-compound drugs, drug categories

The US Food and Drug Administration (FDA) is proposing the creation of two lists of drugs or drug categories that are difficult to compound...

USA – FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy

Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic...
Coronavirus delays many FDA foreign inspections

USA – FDA offers guidance on minor label changes for OTC drugs

The US Food and Drug Administration (FDA) has clarified definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs in draft guidance...

USA – FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty...

Today, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced...

USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...

FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...

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