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 106

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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Pharmaceutical Companies FDA Pharmaceutical Companies Communication 59

The FDA Law Blog

JUNE 7, 2023

Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). Second, Merck argues that the parody of a negotiation and a fair price compels speech in violation of the First Amendment.

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Communication 45

Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995. GlobalData is the parent company of Pharmaceutical Technology.

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Vaccines Immunization Medical Schools FDA 59

The FDA Law Blog

JUNE 14, 2023

In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers. It remains to be seen how FDA would define and actually implement the role of a TAP Advisor.

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FDA Communication 45

The FDA Law Blog

NOVEMBER 17, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).

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Communication FDA 69

The FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).

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Communication FDA 59

ISPE

SEPTEMBER 11, 2023

Nature Communications 12, no. 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.” Biotechnology Progress 36, no.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years. 6 (2018): 649–655. FiercePharma.

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Compounding Compounding Pharmacies Packaging FDA 52

The FDA Law Blog

JULY 10, 2025

Texas Goes BIG on Food Warnings Beginning on January 1, 2027, Texans may notice new warning labels on some food products sold in their fair state. This labeling requirement will apply to packages “developed or copyrighted” from January 1, 2027 onward. For more information about this ingredient, including FDA approvals, click HERE.”

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Labelling Packaging FDA Communication 66