NDA is the vehicle in the United States used by the sponsor of the Drug officially informing the FDA department United States to review the documents of the proposed...
The pharmaceutical industry is the highly regulated industry in the world. Every pharmaceutical manufacturing company has to face various audits by the Drug department and other players. To comply...
Humira is a brand name of Adalimumab drug manufactured by AbbVie company in the United States. It is a tumor Necrosis Factor (TNF) blocker that is used to reduce...
The pharmaceutical industry in the US has been in existence since the mid-1800 with the origins of Pfizer, J&J, and Merck & Co. The United States counts more than...
The title 21 CFR is a part of the Code of Federal Regulations (CFR) permanent rules published in the Federal Register by the Executive departments and agencies of the...
U.S. Food and Drug Administration approved the most awaited obesity drug Wegovy that contains Semaglutide 2.4 mg in injection form. As per U.S. FDA, the medicine is advised once...
FDA guidelines for high purity water system:- The FDA guidelines are dominating the aspect microbiological conditions of water for injection and purified water systems that are used in the...
USFDA approval is a big milestone for any pharmaceutical manufacturing facility. If you are looking to export medicines to the US then you must have your facility approved by...
The Medicines and Healthcare products Regulatory Agency (MHRA) is a government agency in the United Kingdom. MHRA’s prime role is to regulate medicines, medical devices, and blood components for...
On 22nd October, the U.S. Food and Drug Administration approved the antiviral drug Remdesivir for the first treatment of Covid-19. The use of this drug is limited to adult...
