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

The FDA Law Blog

JUNE 8, 2023

The pandemic had changed the way people live, work and communicate. 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., However, not all changes are forever.

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FDA Communication Documentation 53

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

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Results from this trial are scheduled to be released in October 2027, and may allow non-diabetic obese patients to have access to Mounjaro. The drug was approved to treat type 2 diabetes mellitus in May.

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Labelling Insurance Communication FDA 105

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Results from this trial are scheduled to be released in October 2027, and may allow non-diabetic obese patients to have access to Mounjaro. The drug was approved to treat type 2 diabetes mellitus in May.

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Labelling Insurance Communication FDA 98

PharmaShots

FEBRUARY 22, 2023

Some of its FDA-approved competitors include: Patents7 Eli Lilly carries big expectations from Trulicity to boost its revenue. In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026). Trulicity has been a part of over 2.8 million patients’ journeys with type 2 diabetes since 2014.

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Insurance Compounding Dosage Communication 64

Pharmaceutical Technology

FEBRUARY 6, 2023

The FDA approved both drugs in 2014. On February 2, the FDA cleared an Investigational New Drug Application for PLN-101095. The standard treatments for IPF include Esbriet ( pirfenidone ) which is marketed by Genentech, a part of Roche, and Boehringer Ingelheim’s Ofev ( nintedanib), which are used to slow disease progression.

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FDA Pharmaceutical Companies Pharmaceutical Companies Communication 59