Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. There is also a debate as to how genomic information should be protected,” he adds.

Genomics 276

Genomics Genome Regulation Compliance 276

Camargo

NOVEMBER 11, 2020

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).

Development 242

Development Bioequivalency Generic Drugs Production 242

FDA Law Blog

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however.

Gene 64

Gene DNA Genetics Gene Sequencing 64