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FDA Strengthening Good Clinical Practice Oversight

Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globalized clinical trial en...

Human Drugs

FDA Wants Botanical Drug Development Input

FDA publishes a request for information on stakeholders views on ways to accelerate botanical drug development.

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Human Drugs

Shoolin Pharma Insanitary Conditions, CGMP Issues

FDA warns Indias Shoolin Pharma Chem that it is producing active pharmaceutical ingredients in insanitary conditions and with significant CGMP deviati...

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Human Drugs

Boxed Warning for Injectafer on Low Phosphate Levels

FDA orders a Boxed Warning for American Regents Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia.

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Biologics

uniQure Files BLA for Huntingtons Gene Therapy

Following a course reversal by FDA, uniQure files a BLA seeking accelerated approval of ifezuntirgene inilparvovec (AMT-130), an investigational gene ...

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Human Drugs

Early Alert: Convenience Kit Issue from AVID Medical

CDRH issues an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain kits be corrected prio...

Human Drugs

Cancer White Paper on Dosage Optimization

A Friends of Cancer Research white paper recommends a new approach to support administered activity escalation and dosage optimization in developing r...

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Human Drugs

Pediatric Research Policy and Procedure

CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Act and the Best Pharm...

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Human Drugs

Stakeholder Suggestions to Improve Gene Therapy Draft Guidance

Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene therapy products.

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Human Drugs

CGMP Violations Seen at Indias Reliance Life Sciences

FDA warns Indias Reliance Life Sciences about significant CGMP violations in its production of finished drugs.