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 – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
USA – FDA outlines process for recognizing standards for regenerative medicines
The US Food and Drug Administration (FDA) has issued final guidance describing its process for recognizing voluntary consensus standards (VCS) to spur the development...
USA – Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling
Two major pharmaceutical industry groups opposed the US Food and Drug Administration’s (FDA) proposal to remove details about interchangeability from product labels in its...
USA – FDA issues new standards for DTC prescription drug ads
The US Food and Drug Administration (FDA) published its final rule changing how companies must present the “major statement” in direct-to-consumer (DTC) TV and...
USA – Global Pharma’s eye drops contaminated with “filth” while Amazon made unapproved claims...
The US Food and Drug Administration (FDA) lambasted India-based Global Pharma Healthcare in a 14 November warning letter for manufacturing eye drops that have...
USA – Industry calls for revisions in FDA’s CGT manufacturing change guidance
Pharmaceutical industry and regenerative therapy groups want the US Food and Drug Administration (FDA) to take a more nuanced approach in guidance on reporting...
USA – FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus
Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older...
USA – FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder
Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme...
USA – FDA finalizes guidance on real-time review of oncology drugs
The US Food and Drug Administration (FDA) has finalized its guidance that outlines the eligibility and submission requirements for applicants interested in submitting new...
