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.

Documentation 59

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 The Computer Software Assurance (CSA) concepts published as draft guidance by the FDA and that are already embedded in GAMP ® 5 Second Edition will be discussed in detail.

Documentation 98

Documentation FDA 98

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.

Packaging 52

Packaging FDA Documentation Vaccines 52

ISPE

OCTOBER 27, 2022

Project RiskSurve from FDA: a project to create a comprehensive site surveillance model consolidating data from different dimensions: what are the first learnings? Brooke Higgins, Senior Policy Advisor for the Global Compliance Branch 3, FDA has chosen the following title for her presentation: “Testing Positive….

Dosage 98

Dosage Vaccines FDA Documentation 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.

FDA 52

FDA Documentation 52

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

FDA 98

FDA Insurance Chemotherapy Documentation 98

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™

Documentation 98

Documentation FDA Communication Labelling 98