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Dec 22, 2023 · Content of labeling means: (1) For human prescription drugs that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act: The content of the prescription drug labeling (as specified in §§ 201.56, 201.57, and 201.80 of this chapter), including all text, tables, and figures. (2) For ...
FDA authority to regulate proprietary names is based on statute and regulations. The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 321(n) states that a drug may be misbranded if “the...
- I. Background
- II. Paperwork Reduction Act of 1995
- III. Electronic Access
FDA is announcing the availability of a guidance for industry entitled “Best Practices in Developing Proprietary Names for Human Prescription Drug Products.” This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the FD&C A...
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521) is not required for this guidance. The previously approved collections of information ...
Persons with access to the internet may obtain the document at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Exclusivity is a period of time when a brand-name drug is protected from generic drug competition. There are different exclusivities for different situations. Exclusivity is designed to promote a ...
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Sep 6, 2023 · Depending on the state, approval times for a wholesale drug distributor license can range from weeks to months. Typically you must first obtain a license in your resident or domestic state. In Alaska, this process is relatively straightforward, and a license can be issued in two to three weeks. In California, the process is more tedious and ...
This guidance is intended to assist industry in the submission of a complete 61 package of information that FDA will use in the assessment both of the safety aspects of a 62 proposed. proprietary name. to reduce medication errors, and of the promotional implications of 63 a proposed name, to ensure compliance with other requirements for.
Proprietary name - The name that will be used by the applicant or other entity for the commercial distribution of the product. Note: This is most often the trade name of the product. V. Policy.
