FDA Review Procedures PDF

REVIEW PROCEDURES Once a complete application (NDA, BLA, ANDA) is filed with FDA for review, it is sent to the concerned Center for Review. FDA charges an application fee for reviewing NDA and BLAs (ANDAs are not charged any review fee). After receiving the application for review, the Cen...

REVIEW PROCEDURES Once a complete application (NDA, BLA, ANDA) is filed with FDA for review, it is sent to the concerned Center for Review. FDA charges an application fee for reviewing NDA and BLAs (ANDAs are not charged any review fee). After receiving the application for review, the Center designates a project manager who is responsible for coordinating the review. The project manager is the primary point of contact for the applicant for any type of communication.  Following are typical phases of the review cycle: Application is checked in the document control center. Application is checked for completeness of content and technical details. This helps the center to determine whether a worthwhile review is possible (Time limit: Within 60 days of receiving the application). If the application is complete, an “Acceptance to file” letter is sent to the applicant. If the application is incomplete, a “Refuse to File (RTF)” is sent to the applicant. If an “RTF” is received, the applicant must provide all the required information.  The FDA will initiate the review only after receiving the complete documents. Different sections of the application are distributed to the review team. Applications are taken up for review based on the priority procedure. Applications are labelled standard (S category) or priority (P category) review based upon the type of application. AIDS drug applications are high-priority (AA category) review drug applications. During the review cycle, a 90-day meeting can be held between the applicant and the FDA to discuss the progress and issues. Issuance of action letter: An action letter is issued by the FDA (project manager) to the applicant (timeline: Within 180 days of the “Acceptance to file” letter). This letter is issued after the technical evaluation of different sections of the application is completed by respective offices. If the application is completely acceptable, an “Approval Letter” is issued. If there are some problems, a “Not Approvable Letter (major problems)” is issued which means that the application is not approvable, or an approvable letter (minor problems) is issued if the application can be approved after addressing the deficiencies. These problem letters summarize the deficiencies in the application and also tell what needs to be done (if something can be) in order to approve the application.  Telephonic amendments: The FDA may ask for some additional clarifications/data to support an efficient review of the application. Response has to be submitted within 10 working days.  Minor amendments: Response has to be submitted within 60 working days of receiving the deficiency letter.  Major amendments: Response has to be submitted within 180 working days of receiving the deficiency letter.  Review of the application is stopped when the applicant is responding to a minor or major deficiency. If the applicant does not respond to minor deficiencies within 60 days, the category is changed to a major amendment. Review is not stopped in case of telephonic amendment. CERTIFICATION OF DRUGS Insulin and antibiotics are the two classes of drugs requiring certification, although certain antibiotics may be exempt from certification. The FDA, acting under the mandate of the Act, has adopted regulations to ensure that each batch has the characteristics of identity, strength, quality, and purity prescribed in such regulations. Application for certification must be made to the Commissioner. In 1982, the FDA published a regulation that exempts virtually all antibiotics from the requirement of obtaining batch certification.  For 20 years, companies marketing approved antibiotics had been required to submit assay results and samples of each manufacturing batch for FDA testing and evaluation. The purpose of this exercise was to assure batch-to-batch integrity and uniformity, and this testing was paid for by the companies involved and was both costly and time-consuming (a batch could not be released for sale until the FDA passed it). Apparently finding the exercise no longer justified, the FDA dropped it. Batch confirmation continued to be required for insulin products. INTELLECTUAL AND INDUSTRIAL PROPERTY  The term “intellectual and industrial property” generally is understood to refer to patents, trademarks, and copyrights.  There is also that nebulous something called “knowhow” and that further something called “trade secrets”. a patent is a statutory grant of monopoly for a period of years during which an inventor can exclude others from making, using, or selling his invention. The right is absolute as long as the validity of the patent is upheld. A trademark, on the other hand, does not derive its value or indeed its validity from a statutory grant. The right to the exclusive use of a trademark is derived primarily from the common law in that it must be properly used by the person claiming ownership, and such use may be challenged by another even though there is a federal or state registration. Registration is merely a procedural tool in that it serves as notice of use and claim of ownership. A copyright (often confused with a trademark) is a statutory grant given to creators of artistic or literary works, so that they might enjoy the fruits of their intellectual labors for a period of years without fearing plagiarism or other copying. Know-how is a term widely used to describe the accumulated knowledge of a person, a group of persons, or, in some instances, a corporate entity. It describes the general intelligence concerning either the manufacturing or particular steps in the manufacturing, of a product or products and embraces the experience of years, largely empiric, that is generally claimed to impart particular qualities of elegance or superiority to the product manufactured in that manner. “Know-how,” if not patentable, is carefully husbanded by the owner and usually passed on only to those who need to know in order to continue the production of the product. In general, it is knowledge that is common, but that involves a particular application within the production procedure to accomplish its beneficial results. Trade secrets, on the other hand, are generally those bits of knowledge or ingenuity that may well be patentable, but for reasons best known to the keeper of the secrets, are not imparted to the general public. One explanation for the keeping of a trade secret is that if it is exposed in a patent, it can only be monopolized for a short period of years, generally 17, after which it can be used by others with impunity. As long as the secret is kept a secret, its use can be exclusive for an indefinite period. The law recognizes and protects genuine trade secrets.