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In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs). These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of ...
summary. The summary required under this paragraph may be used by FDA or the applicant to prepare the Summary Basis of Approval document for public disclosure (under 314.430(e)(2)(ii)) when the application is approved. (2) The summary is required to contain the following information:
The Federal Register system of publication was created on July 26, 1935, under the Federal Register Act. [ 4 ] [ 14 ] The first issue of the Federal Register was published on March 16, 1936. [ 15 ] In 1946 the Administrative Procedure Act required agencies to publish more information related to their rulemaking documents in the Federal Register .
May also contain results of various clinical trials (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.). Indications and Usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure).
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
The FDA has issued a statement following the Class I recall for an IOS app used in conjunction with insulin pumps after 224 injuries were reported. ... May 9, 2024 at 12:00 PM.
The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. [2] REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacture of the brand name ...
The Act further sets forth a broad range of powers that the FDA may exercise in order to prevent distribution of adulterated or misbranded food. In addition to the express powers set forth in the statute, the FDA exercises certain implied powers, such as the issuance of Warning Letters and recall orders.