The FDA Law Blog

SEPTEMBER 16, 2024

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.

Documentation 59

Documentation FDA Communication 59

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.

Documentation 98

Documentation FDA Communication 98

The FDA Law Blog

MAY 13, 2024

Further, FDA has stated that enabling advanced data analytics, including RWD, is one of the objectives incorporated in the FDA’s Information Technology Strategy for FY 2024-2027. This guidance, when finalized, will replace the original version of this document finalized in 2017.

FDA 111

FDA Medical Records Documentation 111

The FDA Law Blog

JUNE 8, 2023

It is also crucial to maintain a respectful and cooperative demeanor, document the meeting discussion and action items, and promptly address follow-up actions. FDA notes that all in-person FTF formal meetings at CDER and CBER will have a hybrid component (virtual attendees in addition to in-person attendees).

FDA 53

FDA Communication Documentation 53

pharmaphorum

OCTOBER 1, 2022

The latest judgments relate to an attempt by Chinese drugmaker HEC Pharma to bring a generic version of fingolimod to market in the US, and Novartis defense of the 9,187, 405 patent which expires in December 2027.

Documentation 52

Documentation 52

Pharmaceutical Technology

NOVEMBER 4, 2022

At the time of its publication, the document prioritised the finalisation of Brexit above all else. of gross domestic product (GDP) in R&D by 2027. In a more recent report, the ABPI found that the number of Phase III industry trials fell by 48% between 2017 and 2021.

Documentation 93

Documentation Pharmaceutical Companies Pharmaceutical Companies 93

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