Genotoxicity Marketing Production Regulation 
XTalks
MAY 13, 2022
A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container closure systems are highly regulated by health agencies.
The Pharma Data
FEBRUARY 8, 2021
This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Food and Drug Administration (FDA). 2,3 In the U.S.,
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FDA Law Blog
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
The Pharma Data
MARCH 25, 2021
Chief Development Officer, Oncology, Pfizer Global Product Development. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. 2,3 In the U.S.,
Drug Discovery World
MAY 10, 2023
This stage is more highly regulated and consists of both preclinical testing and clinical trials. Specific guidelines set forth to regulate these testing processes are issued by the ICH, a non-profit organisation with representation from global regulatory agencies and pharmaceutical companies.
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