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FOPE & PharmaState Academy host Session 12 of the PULSE series

Express Pharma

On December 29, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 12 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Complaints and Product Recall. The session provided clarity on the guidelines and cleared the queries of the pharma professionals.

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Medical Writing in Enhancing Healthcare Communication

Viseven

It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication. As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences.

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FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

Big Molecule Watch

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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FOPE and Pharma State Academy focus on Quality Risk Management in latest PULSE session

Express Pharma

FOPE and Pharma State Academy recently hosted, third session of their PULSE series on August 11, 2024, spotlighting “Quality Risk Management (QRM)” with a special focus on the Revised Schedule M. The panel also discussed the differences between ICH Q9 and the Revised Schedule M, and the importance of meticulous documentation.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog: Biosimilars

Below we highlight FDA’s views about best practices for BIMO inspection communications, handling requests for records, and inspection preparation and follow-up as outlined in the draft guidance. Communication Best Practices During a BIMO Inspection Provide timely and accurate responses to information requests.

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NHC Comments on Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Prescription Payment Plan Model Documents (CMS-10882) – IRA

Putting Patients First Blog

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.