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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

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Gerresheimer enhances pharma packaging registration with comprehensive product database

Express Pharma

By offering comprehensive and audit-proof documentation, the platform aims to simplify regulatory approvals and reduce time-to-market for pharmaceutical companies. It contains revision dates, test results, certifications, and regulatory documentation. Production departments assess filling-line compatibility and labelling formats.

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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).

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Gilead takes legal action against counterfeit HIV drug network 

pharmaphorum

According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin. This works to ensure the safety and efficacy of the drugs received by patients.

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FDA Issues Guidance on Biosimilar Labeling

Pharmaceutical Commerce

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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FDA Issues Guidance on Biosimilar Labeling

PharmaTech

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Experts to come together for compliance event ‘validation ready’ global labeling systems  

pharmaphorum

exploring ‘validation ready’ global labeling systems . ? . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. The post Experts to come together for compliance event ‘validation ready’ global labeling systems appeared first on.