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

The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

FDA 111

FDA Medical Records Documentation 111

ISPE

NOVEMBER 23, 2022

Some of the highlights of the presentations given during the Symposium were as follows: The PIC/S Chairperson, Paul Gustafson, Health Canada, presented on PIC/S’ new strategic plan for 2023-2027 which covered the following elements: Promote, improve and monitor inspection reliance amongst PIC/S member authorities.

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Documentation FDA Communication 98

The FDA Law Blog

JUNE 8, 2023

FDA has begun to reintroduce in-person meetings. It is also noteworthy that in the March 27 announcement , FDA distinguished between teleconferences and videoconferences despite using the same online platform (e.g., Applicants should also be aware that FDA has the discretion to decide the format of the meeting (e.g.,

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FDA Communication Documentation 53

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

pharmaphorum

JANUARY 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. Guest FDA Speaker: John Barr Weiner, Associate Director for Policy and Product Classification Office, Office of Combination Products FDA. . The global pre-filled syringes market was valued at $1139.6

Packaging 52

Packaging FDA Documentation Vaccines 52

ISPE

SEPTEMBER 11, 2023

Fill Finish Manufacturing Market by Product (Consumables (Prefilled Syringes (Glass, Plastic), Vial (Glass), Cartridge), Instrument (System (Stand alone, Integrated), Machine Type (Automated, Manual))), End User (CMO, Biopharma) & Region - Global Forecast to 2027.” September 2022. 25%20from%202022%20to%202027 24 Eglovitch, J. 7 March 2023.

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Health and Personal Care Stores Vaccines Packaging Documentation 52