Pharmacovigilance – Drug Application

Recently Federal Laws stated that “a drug should be the subjected to an approved marketing application earlier than it is transported or spread. Since promoter wants to ship this drug to different clinical investigators in various states, it should seek a release from that legal requirement.”

The Investigational New Drug (IND) is an application through which the sponsor officially gets an exemption from the FDA. There are three type of investigational new drugs. (IND): Investigator IND, Emergency use IND and Treatment IND. The Investigator IND is submitted via a physician who initiates and conducts an investigation on drugs, and this investigational drug is administered or dispensed by his immediate directions. The Emergency use IND permits the FDA to use this drug in emergency and it does not allow any definite time for submission of IND according to law 21 CFR, Sec. 312.23 or Sec. 312.34. The Treatment IND is submitted for experimental drug showing clinical testing during clinical trials. GAP has a professional team of physicians, who would submit an IND on behalf of the company to suggest a study of an unapproved medication.

The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose a drug.When safety and effectiveness of drugs meet the standard of FDA.
then the drug sponsor submits this drug to FDA a New Drug Application (NDA) for sale and marketing in the U.S.A. This application contains specific data such as pharmacology, chemistry, medical, statistics, and bio-pharmaceutics.

Biologic license application (BLA) requires submission specific information such as pharmacology, clinical pharmacology, chemistry, manufacturing process and the medical effects of different biologic product. If the information meets with the standard of FDA then it accepts applications and provides the license for marketing the drug in the market. These biological products are permitted under the Public Health Service (PHS) Act for marketing.
GAP has three complete NDA submissions. GAP adheres to the guidance, regulations, and the sponsor’s Standard Operating Procedures (SOPs) to effectively file your NDA. We are completely aware of NDA review principles, policies and procedures. GAP can also extend their support to the legal requirements of the NDA at all levels.

Contact us for more information.