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Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
Novartis AG is a publicly traded Swiss holding company that operates through the Novartis Group and owns, directly or indirectly, all companies worldwide that operate as subsidiaries of the Novartis Group. [110] Novartis's businesses are divided into two operating divisions: Innovative Medicines and Sandoz (generics). [111]
This list of pharmaceutical compound number prefixes provides codes used by individual pharmaceutical companies when naming their pharmaceutical drug candidates. . Pharmaceutical companies generally produce large numbers of compounds in the research phase for which it is impractical to use often long and cumbersome systematic chemical names, and for which the effort to generate nonproprietary ...
Pazopanib, sold under the brand name Votrient, is an anti-cancer medication marketed worldwide by Novartis. It is a potent and selective multi-targeted receptor tyrosine kinase inhibitor that blocks tumour growth and inhibits angiogenesis.
The letters are so called after Cyril Salmon, Baron Salmon, who first conceived of the idea in 1966 when chairing a report into how tribunals of inquiry were to be conducted. [ 2 ] The letters are also known as Maxwellisations after Robert Maxwell , who complained after criticism of his dealings in a public report. [ 3 ]
An Estoppel Certificate (or Estoppel Letter) is a document commonly used in due diligence in real estate and mortgage activities. It is based on estoppel, the legal principle that prevents or estops someone from claiming a change in the agreement later on. [1] It is used in a variety of countries for commercial and residential transactions.
The "beta crystalline form" of the molecule is a specific polymorph of imatinib mesylate; a specific way that the individual molecules pack together to form a solid. This is the actual form of the drug sold as Gleevec/Glivec; a salt (imatinib mesylate) as opposed to a free base, and the beta crystalline form as opposed to the alpha or other form.