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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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Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Drug Patent Watch

Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S. Global Harmonization Efforts There are ongoing efforts to harmonize bioequivalence standards and PSG-like documents across regulatory agencies worldwide.

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FOPE & PharmaState Academy hosts session 15 PULSE Program

Express Pharma

In-depth presentation: The expert education session, conducted by Rajendra N. He explained the difference between incidents and deviations, stating that deviations are departures from written procedures, while incidents are unplanned events, reinforcing the need for clear SOPs and proper documentation.

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Session 14 of FOPE & PharmaState Academy’s PULSE Program explores investigations & CAPA under Revised Schedule M

Express Pharma

Presentation Highlights: Balwinder Kaur provided an in-depth analysis of the Revised Schedule M, focusing on its strengthened pharmaceutical quality system requirements. Emphasising a proactive rather than reactive approach, she urged organisations to mitigate risks through thorough root cause analysis (RCA) and systematic documentation.

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SAEM Clinical Images Series: A Curious Case of Anisocoria

ALiEM - Pharm Pearls

The patients mother noticed her sons left pupil was dilated and unresponsive to light the morning of presentation. Other documented pharmacological causes of anisocoria include nebulized ipratropium bromide and scopolamine (14-19). Physical Exam Vitals : BP 85/66; HR 143; RR 42; SpO2 100%; T 98.3F J Am Acad Dermatol. 2020;83(4):e275.

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FOPE & PharmaState Academy host Session 12 of the PULSE series

Express Pharma

The session was led by A V Jayakumar, President- Quality, Ajanta Pharma Presentation highlights Jayakumar provided valuable insights from his extensive experience in quality management and regulatory compliance. He recounted his own experience working with investigative teams and the importance of being proactive when handling complaints.

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Addressing US FDA challenges in Indian sterile drug manufacturing – Part 2

Express Pharma

Rising expectations for scientific rationale One consistent theme across FDA communications, including 483s, Warning Letters, and guidance documents is the demand for sound scientific justification behind design and operational decisions. Interventions were neither documented nor risk-assessed.