European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

Pharmaceutical Technology

OCTOBER 28, 2022

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

Pharma in Brief

JANUARY 10, 2024

The Guidance was last updated in 2005. The Court found that it was “not in the public interest” to require patients taking the infringing biosimilar to switch medications, as the infringing product was “the only 80 mg/0.8 The Guidance outlines the factors that contribute to rendering a message or activity promotional in nature.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 52

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order. a); OTC Monograph M012: § M012.20.

Pharmacy Management 111

Pharmacy Management Dosage Documentation 111