Drug Patent Watch

DECEMBER 10, 2024

This article will delve into the importance of scientific expertise in generic drug development, highlighting the key areas where scientific knowledge is essential. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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Drug Development Pharmacokinetics Compliance Drugs 98

Agency IQ

AUGUST 16, 2024

Areas of expertise included psychiatry, post-traumatic stress disorder, emergency medicine, pharmacy and medication safety, and statistics. The meeting’s roster included five voting members from PDAC, six temporary voting members, and one non-voting industry representative.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. Other comments from the American College of Clinical Pharmacy (ACCP) and American Association of Colleges of Pharmacy (AACP) also endorsed the actions sought in the Citizen Petition. hours, the drug is no longer physiologically active.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article. Still, the article served to reinforce the primacy of OS as a primary endpoint in oncology trials. However, the proper use of some non-OS endpoints has been called into question in recent years.

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40

Advarra

DECEMBER 14, 2022

Pharmacy manual. Safety, quality of life, and pharmacokinetic (PK) responses are not considered to be therapeutic objectives. These assessments are supported by Medicare-approved guidelines and/or journal articles. Identifies what items/services sponsor reimburses, and therefore not eligible for Medicare coverage. Lab manual.

Clinical Trials 52

Clinical Trials Trials Compliance FDA Approval 52