The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. 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.

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Documentation FDA Communication 59

ISPE

JULY 19, 2023

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. ™, driven by the recognition that digital transformation offers a big chance to finally realize the US FDA’s Pharmaceutical Quality for the 21st Century Initiative to the full extent. to a pharma-specific Pharma 4.0™

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Documentation FDA Communication Labelling 98

ISPE

SEPTEMBER 8, 2023

In addition, this article provides an explanation of the purpose and expected outcomes from the survey, subsequent plans for communicating the results from the survey across ISPE, and development of concrete proposals to address the sources of challenges and barriers to innovation. 22 June 2023. link] 16 US Food and Drug Administration.

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FDA Documentation Dosage Communication 52

Pharma Marketing Network

JUNE 8, 2020

Both from an HCP marketing and communications and for patients, direct to consumer, and patient platforms. Working in both marketing and advertising campaigns but also market research, strategic planning, workshop facilitation. Yet I can tell you, I can go into a doctor’s office and freeze and won’t know what to say.

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Communication Insurance Hospitals FDA 40

ISPE

JUNE 27, 2023

The session included regulators from the European Medicines Agency (EMA), the UK Medicines & Healthcare Products, Regulatory Agency (MHRA), the Spanish Agency of Medicines and Medical Products (AEMPS) and the US Food and Drug Administration (FDA). In answer to the question, what does the industry have to do?

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Communication FDA Vaccines 52

ISPE

JULY 5, 2023

7 A critical feature of the ETP is representation from all relevant FDA quality assessment and inspection programs, from early engagement with stakeholders through application submission and assessment. 13 An FDA-authored paper indicating support for the implementation of CM using science- and risk-based approaches followed soon thereafter.

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FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Wireless medical devices.

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Health and Personal Care Stores FDA Communication Clinic Management 52