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

MARCH 3, 2023

On the contrary, it should enable innovation by ensuring that systems are fit for the intended purpose without creating an excessive documentation burden. The Computer Software Assurance (CSA) concepts published as draft guidance by the FDA and that are already embedded in GAMP ® 5 Second Edition will be discussed in detail.

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Documentation FDA 98

The FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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FDA Documentation 52

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 Labelling Communication 98

ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. A final report will be provided as the basis for an ISPE workshop, with recommendations subsequently published in Pharmaceutical Engineering and other trade publications. 22 June 2023. 22 June 2023. EMA/321483/2020.

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FDA Documentation Dosage Communication 52

pharmaphorum

JANUARY 18, 2022

Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. Guest FDA Speaker: John Barr Weiner, Associate Director for Policy and Product Classification Office, Office of Combination Products FDA. . POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. SMi’s 9th Annual Conference.

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Packaging FDA Documentation Vaccines 52

The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020. by the end of 2023).

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FDA Documentation Labelling 59