ANDA and ANADA, FDA's Fast Lane To Getting Into Business
John is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. John retired from the FDA’s Office of Cosmetics and Colors in June 2019 where he served as an SME in the areas of personal care product microbiology and manufacturing (GMP’s). Prior to FDA John served in a global capacity with Estee Lauder Companies responsible for regulatory compliance in all manufacturing facilities. In 1982 John took over the helm of Food and Drug Standards Manager for the State of Wyoming Department of Agriculture, where he became an internationally recognized leader in the adaptation of HACCP principles to regulatory programs. John was promoted to Deputy Commissioner of Agriculture prior to leaving for Este Lauder.
John Grew up on a farm in Ohio where he learned a great deal about self-reliance, resilience, and creativity. Leaving the farm to start his journey, John graduated from The Ohio State University and the University of Wyoming. The skills that John learned in those early years bring him to you today. If you have a chance, ask John about his experience as a shepherd in Wyoming’s Big Horn Mountains. John is also a musician and vocalist, something he has enjoyed since performing professionally at age 16.
The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established bioequivalence as the basis for approving generic copies of drug products. These Amendments permit FDA to approve applications to market generic versions of brand-name drugs without repeating costly and duplicative clinical trials to establish safety and efficacy. In addition, generic drug companies gained the ability to challenge patents in court prior to marketing as well as 180-day generic drug exclusivity.
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug. Bioequivalence is the determination that the rate of absorption, or bioavailability, of the generic drug, is basically the same as the innovator drug. To be approved by FDA, the generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.
The Generic Drug User Fee Amendments (GDUFA I)2 31 was signed into law on July 9, 2012. Approximately half of all ANDAs with GDUFA I review goals required three or more review cycles to reach approval or tentative approval. FDA and industry negotiated a revised agreement, GDUFA II and GDUFA were reauthorized on August 18, 2017. GDUFA II includes important program enhancements that are designed to improve the predictability and transparency of ANDA assessments and to minimize the number of review cycles necessary for approval. These program enhancements are intended to foster the development of high-quality submissions, ensure the timely resolution of filing reconsideration requests, promote the correction of deficiencies in the current review cycle, and support the development of high-quality resubmissions. An applicant must provide, in its ANDA, information related to any patents listed for the RLD in FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange 84 Book).
Generally, an ANDA’s labeling must be the same as its RLD’s labeling. DMF holders should include information on the control of materials used in the manufacture of the drug substance and provide a justification for the starting material selection for the process. The DMF requires a complete description of the API manufacturing process as part of a complete description of the API manufacturing process. An ANDA for an aseptically processed generic drug product requires in-process acceptance criteria for the total number of microorganisms associated with the unfiltered bulk drug solution prior to its sterilization (bioburden) because the “bioburden can contribute impurities (e.g., endotoxin) to, and lead to degradation of, the drug product. It is critical for applicants to submit complete bioanalytical study reports and to validate bioanalytical methods used in their BE studies, including clinical summary data from in vivo BE studies with properly formatted tables summarizing various aspects of the BE submission. In original ANDA submissions, applicants should include all of the BE and safety information related to the conduct of in vivo BE studies that are listed in the FDA draft guidance for industry ANDA Submissions — Content and Format of Abbreviated New Drug Applications.
Similar processes apply to generic animal drugs, except under different laws and regulations and different acronyms. An ANADA is used to seek approval of a generic new animal drug. A generic new animal drug is a copy of an approved new animal drug (RLNAD) for which patents or other periods of exclusivity are at or near expiration. The Generic Animal Drug and Patent Term Restoration Act (GADPTRA) is the law that defines what a generic animal drug ANADA is. RLD becomes RLNAD for animal generics. The approved RLNAD that the generic sponsor intends to copy must be identified (Can be found in the Green Book, as opposed to the Orange Book for human drugs). Information needed to include in the submission is similar, including bioequivalence and manufacturing methods. There are additional requirements, including a tissue residue depletion study if it is intended for use in food-producing animals, an environmental assessment (EA), or a request for categorical exclusion from the requirement to prepare an EA. In some cases, CVM requests samples of the product, and an FOI Summary, which summarizes the studies forming the basis of approval of the ANADA. The biggest difference is that an ANADA is submitted to CVM, not CDER.
ANDA, ANADA, Hatch-Waxman Amendments, bioequivalence, generic drug, Orange Book, GDUFA I and II, innovator drugs, RLD, therapeutic equivalence, tentative approvals, review cycles, Form FDA 356h, DMF, aseptically processed generic drug product, GADPTRA, validated bioanalytical study data, bioequivalence deficiencies, RLNAD, Green Book, tissue residue depletion study, FOI, CDER, CVM.
Course Level - Intermediate and Advanced
Who Should Attend
- Brand Managers
Why Should You Attend
When patents expire on branded drug products there is an opportunity to enter the generic human or animal drug market by utilizing shortcuts in the law that Congress provided for that purpose. The cost of bringing a generic drug to market is much less than trying to navigate the NDA/NADA route. To allow for more competition in the OTC and prescription drug markets, amendments were made to the FD&C Act to allow firms to piggyback on phase I and II safety and efficacy data submitted under an approved NDA/ANDA. To successfully receive approval for a generic human or animal drug and avoid a lengthy approval process, there are several steps that, if submitted properly, will assure rapid FDA approval. Learn what products are acceptable for ANDA/ANADA, how to successfully submit an application, obtain required bioequivalence testing and get your submission approved. What is “A” in ANDA/ANADA? What is bioequivalence? What is involved in submitting the necessary studies? Do I need to worry about GDUFA or GADPTRA? Get answers to specifics of preparing and submitting an ANDA or ANADA. Anyone interested in understanding the complexities of bringing a generic human or animal drug to market should attend this webinar. Participants will learn the meaning of the seemingly endless acronyms associated with the process of bringing generics to market and allay any fears of treading into this potentially lucrative arena. When drugs go off-patent, the door is opened to rebrand proven products. You will come away with a better understanding of the mechanics involved to introduce new generics into the marketplace.