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STAT+: Senator launches investigation into GSK’s asthma inhaler maneuvers

STAT

In a letter sent to the company, the lawmaker maintained that the decision to discontinue its inhaler in January 2024 has since had “life-threatening consequences for patients” and contributed to a spike in hospitalizations.

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What is Digital Communication: Comprehensive Explanation with Examples

Viseven

Have you ever stopped to wonder how your communication methods are shaping patient loyalty? A 2024 survey from Bandwidth revealed that nearly half of patients would consider switching healthcare providers if their communication needs weren’t met. What is Digital Communication?

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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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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.

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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.