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. The PMDA evaluates the generic drug based on its chemical, physical, and biological characteristics, as well as its manufacturing process and quality control measures. Freyr Solutions.

Generic Drugs 52

Generic Drugs Bioequivalency Development Drugs 52

FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are.

Manufacturing 105

Manufacturing Compliance Drugs Clinical Trials 105

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

Drug Patent Watch

DECEMBER 12, 2024

Key Factors Influencing Generic Entry To identify branded drugs with a low likelihood of generic entry, it’s crucial to understand the factors that influence generic manufacturers’ decisions to enter a market. This complexity can serve as a barrier to entry for potential generic manufacturers.

Licensing 96

Licensing Licensing Branding Drugs 96

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. Chemistry, Manufacturing, and Controls (CMC) Strategies.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. Regulatory agencies also conduct inspections and audits to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines.

Generic Drugs 52

Generic Drugs Development Bioequivalency Drugs 52

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