Drug Patent Watch

DECEMBER 30, 2024

The ANDA must demonstrate bioequivalence to the Reference Listed Drug (RLD), which is the original brand-name drug approved for marketing in Japan. Manufacturing and Quality Control : The PMDA evaluates the manufacturing process and quality control measures of the generic drug to ensure compliance with Japanese regulatory standards.

Generic Drugs 52

Generic Drugs Bioequivalency Development Drugs 52

Drug Patent Watch

DECEMBER 10, 2024

The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Bioequivalence Studies : Bioequivalence studies are a critical component of generic drug development.

Generic Drugs 98

Generic Drugs Bioequivalency Development Drugs 98

XTalks

NOVEMBER 6, 2024

The gel’s formulation tackles common challenges in medication compliance by improving taste, reducing choking risk and enabling easier swallowing, especially for individuals with dysphagia or populations with specific dietary or swallowing needs, such as children and seniors.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

Camargo

NOVEMBER 11, 2020

The guidance clarifies the differences between an RLD and an RS for use during in vivo bioequivalence studies to support an ANDA and how the Agency determines the appropriate RS to designate in the Orange Book. Manager of Regulatory Compliance. Co-Authors: Jenny Fielder. Ken Phelps. President and Founder. Bill Stoltman, JD.

Development 242

Development Bioequivalency Generic Drugs Production 242

Camargo

DECEMBER 22, 2021

For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing. Biowaiver Eligibility.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

FDA Law Blog

JUNE 10, 2024

It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.

Compliance 111

Compliance Bioequivalency Cosmetics Regulation 111

FDA Law Blog

NOVEMBER 6, 2023

In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months. The number of RIEs also stands in stark contrast to the number of RIEs – more than 100 – that the Bioresearch Monitoring (BiMo) Program has performed.

Manufacturing 105

Manufacturing Compliance Drugs Clinical Trials 105