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...

USA – FDA publishes two guidances on collecting clinical outcomes data

The US Food and Drug Administration (FDA) has finalized two guidance documents in its series of guidances related to Patient-Focused Drug Development (PFDD). The...

USA – FDA moving in the right direction with psychedelic drug guidance

The US Food and Drug Administration’s (FDA) recent guidance on psychedelic drug development is a “policy landmark” and a step in the right direction...
Coronavirus delays many FDA foreign inspections

USA – FDA ramps up monitoring in high-risk areas following DEG-contamination deaths overseas

The US Food and Drug Administration (FDA) is ramping up its monitoring of firms in areas of the world considered high risk for manufacturing...

USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing

The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...

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