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2. FDA warning letter - Wikipedia

   en.wikipedia.org/wiki/FDA_Warning_Letter

   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]

3. Form FDA 483 - Wikipedia

   en.wikipedia.org/wiki/Form_FDA_483

   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 ...

4. List of pharmaceutical compound number prefixes - Wikipedia

   en.wikipedia.org/wiki/List_of_pharmaceutical...

   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 ...

5. Novartis - Wikipedia

   en.wikipedia.org/wiki/Novartis

   Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland.Consistently ranked in the global top five, Novartis is one of the largest pharmaceutical companies in the world and was the fourth largest by revenue in 2022.

6. Salmon Letters - Wikipedia

   en.wikipedia.org/wiki/Salmon_Letters

   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 ]

7. Everolimus - Wikipedia

   en.wikipedia.org/wiki/Everolimus

   NHS England has been criticised for delays in deciding on a policy for the prescription of everolimus in the treatment of Tuberous Sclerosis. 20 doctors addressed a letter to the board in support of the charity Tuberous Sclerosis Association saying " around 32 patients with critical need, whose doctors believe everolimus treatment is their best or only option, have no hope of access to funding.

8. US FDA sends warning letter to Cardinal Health for marketing ...

   www.aol.com/news/us-fda-sends-warning-cardinal...

   The warning to healthcare providers followed the company's recall over incompatibility concerns with syringe pumps. (Reporting by Pratik Jain in Bengaluru; Editing by Shilpi Majumdar and Sriraj ...

9. New chemical entity - Wikipedia

   en.wikipedia.org/wiki/New_chemical_entity

   A new chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a novel, small, chemical molecule drug that is undergoing clinical trials or has received a first approval (not a new use) by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.