RAC Glossary 2023 Review Update

RAC Glossary 2023 Review Update 21st Century Act - ANS-Amends FD&C Act and PHS Act to include provisions for: patient focused drug development, advancing new drug therapies, modern trial design and evidence development, patient access to therapies and information, antimicrobial innovation and stewardship, medical device innovations, improving FDA expertise and outreach, medical countermeasures innovation, vaccine access, certainty and innovation. 30-Day hold - ANS-Time period between filing a protocol under an IND and FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (See "Clinical Hold.") 120-day Safety Report - ANS-Amendment to an NDA containing a safety update due 120 days after the NDA is filed. 180-day Exclusivity - ANS-Protects an ANDA applicant from competition from subsequent generic versions of the same drug product for 180 days. 505(b)(2) - ANS-An application submitted under FD&C Act section 505(b)(2) for a drug for which one or more of the investigations relied in by the applicant for approval "were not conducted by or for the applicant and for such the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted" Traditional 510(k) - ANS-A premarket notification submitted to FDA to demonstrate that the medical device to be marketed is as safe and effective or "substantially equivalent" to a legally marketed device. 510(k) refers to the section of the FD&C Act authorizing the submission of the premarket notification. Special 510(k) - ANS-A type of 510(k) submission for device modifications neither affecting the intended use nor altering its fundamental scientific technology. FDA processing time is 30 days. Abbreviated 510(k) - ANS-A type of 510(k) submission supported by conformance with guidance document(s), special controls or standards. 513(g) - ANS-Allows device sponsor to request device Classification determination and regulatory information from FDA. Requires a letter with a description of the device and a fee payment. 515 Program Initiative - ANS-Created to facilitate reclassification action on the remaining preamendments Class Ill 510(k)s. Accelerated Approval - ANS-Allows earlier approval of drugs to treat serious diseases and those that fill an unmet medical need based on a surrogate endpoint. Accredited Persons Program - ANS-FDA program accrediting third parties to conduct the primary review of 5 for eligible devices. Action Letter - ANS-Official communication from FDA informing an NDA or BLA sponsor of an agency decision; includes approvable, not approvable and clinical hold. Adulterated - ANS-Product containing any filthy, putrid or decomposed substance; or prepared under unsanitary conditions; or not made according to GMPs; or containing an unsafe color additive; or does not meet the requirements of an official compendium. (FD&C Act, SEC. 501 [351]) advisory committee - ANS-Committees and panels used by FDA to obtain independent expert advice on scientific, technical and policy matters. Application Integrity Policy - ANS-FDA's approach to reviewing applications that may be affected by wrongful acts raising significant questions regarding data integrity ALCOA - ANS-Attributable, Legible, Contemporaneous, Original, Accurate Amendment - ANS-Additions or changes to an ANDA, NDA, BLA, PMA, or PMA supplement still under review. Includes safety updates. Any updates to an IND or an IDE prior to approval are also called amendments Animal Rule - ANS-Provides for approval of certain new drug and biological products based on animal data when adequate and well controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers and field trials are not feasible prior to approval. Anti-Kickback Statute - ANS-Prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate federal healthcare program business. APLB - ANS-Advertising and Promotional Labeling Branch (CBER) BA/BE Studies - ANS-Bioavailability and bioequivalence studies Bad Ad Program - ANS-Truthful Prescription Drug Advertising and Promotion. Education program for healthcare providers to ensure prescription drug advertising and promotion is truthful and not misleading. Administered by CDER's Office of Prescription Drug Promotion (OPDP). Banned Device - ANS-Device presenting a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to public health. Bioequivalence - ANS-The absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. CONTINUES...