USA – FDA investigates risk of secondary malignancies with CAR T-cell therapy
The US Food and Drug Administration (FDA) is investigating reports of a “serious risk” of T-cell malignancies linked to treatment with chimeric antigen receptor...
USA – CBER revises internal procedures for processing clinical holds, NDAs and BLAs
The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has published two internal policy guides for staff outlining procedures for...
USA – FDA issues pharmacy compounding guidance due to amoxicillin shortage
Due to the current shortage of amoxicillin oral antibiotic powder for suspension, the Food and Drug Administration (FDA) has issued guidance on the preparation of...
USA – Biosimilar facilities usually get onsite inspections
A US Food and Drug Administration (FDA) official said that sites making biosimilars will be inspected in person, as opposed to virtual methods, as...
USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
The US Food and Drug Administration (FDA) issued new draft guidance recommending a battery of studies that manufacturers should use to assess the quality...
USA – Industry urges FDA to do more to help companies prepare for DSCSA
The pharmaceutical industry urged the US Food and Drug Administration (FDA) to take a more “assertive and forward-leaning” approach in assisting pharmaceutical manufacturers prepare...
USA – Pfizer: le spray nasal anti-migraine approuvé par la FDA
Pfizer a annoncé vendredi que la Food and Drug Administration (FDA) américaine avait approuvé le Zavzpret, son spray nasal pour le traitement de la...
USA – HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year....
USA – Study: Certain cancer drugs saw widespread use before accelerated approval withdrawal
In the period between when three accelerated approval (AA) drugs received approval from the US Food and Drug Administration (FDA) for oncology indications and...
USA – FDA’s drug approvals in 2022
Last year the FDA’s Center for Drug Evaluation and Research (CDER) approved 37 novel drugs. This is a drop from the highs of the...
