Orange and Purple Book
Holders who intend to make post-approval changes to NDA and ANDA should follow in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act. An applicant must provide Specific information to assess the effect of the change on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug.(more…)
Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval (for an existing licensed approved drug). The ANDA is submitted to the office of Generic drugs, US. After a review of the documents, USFDA gives approval as generic drugs.
After approval, an applicant may manufacture and market the generic drug product to the US market. A generic drug product is one that is similar to branded drug product in dosage form, strength, and route of administration, quality, performance characteristics, and intended use.(more…)
What is Process Life Cycle? The Process Life Cycle or Software Development Life Cycle in systems engineering, information systems, and software engineering, is the process of creating or altering systems,…
The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
The investigational new drug (IND) application is the result of a successful preclinical development program. The IND is also the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials (human trials).
An Abbreviated New Drug Application (ANDA) contains data submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, for review and ultimate approval of a generic drug product.(more…)
Regulatory authorities and agencies Regulatory authorities and agenciesOverview of regulatory authorities of United States, Australia, United Kingdom. International Conference on Harmonization, World Health Organization. ICH TGA MHRA USFDA WHO What…