32 terms in this category. Navigate definitions and jump to related workflows.
Abbreviated New Drug Application (ANDA) is the FDA marketing application for a generic drug, which wins approval by demonstrating bioequivalence to a reference listed drug rather than repeating the clinical safety and efficacy trials behind an NDA.
Accelerated Approval is an FDA pathway that grants marketing approval for serious or life-threatening illnesses on a surrogate endpoint reasonably likely to predict clinical benefit, conditioned on postmarketing studies that verify and describe that benefit.
Annual Reports are the yearly postmarketing filing required for every approved NDA, ANDA, and BLA, covering distribution, labeling, and minor manufacturing changes that do not rise to the level requiring a supplement.
A Biologics License Application (BLA) is the marketing application a manufacturer submits to obtain an FDA license under section 351 of the Public Health Service Act, granted on a demonstration that the biological product is safe, pure, and potent.
A biosimilar is a biological product licensed under section 351(k) of the Public Health Service Act as highly similar to an existing reference product, with no clinically meaningful differences in safety, purity, and potency.
Biosimilar interchangeability is a statutory FDA determination, one tier above biosimilarity, that a biosimilar produces the same clinical result as its reference product in any given patient and may be substituted without the prescriber's intervention.
Breakthrough Therapy Designation is an FDA expedited-development status granted when preliminary clinical evidence indicates a drug may substantially improve on existing therapies for a serious or life-threatening condition on a clinically significant endpoint.
Clinical Trial Application (CTA) is the authorisation dossier a sponsor files with a national or EU regulator before dosing the first subject in a trial of an investigational medicinal product, the non-US counterpart to an FDA IND.
Complete Response Letter is the FDA action letter that closes a review cycle without approval, describing every deficiency the agency identified that a sponsor must resolve before an NDA, ANDA, or BLA can be approved.
Common Technical Document is the ICH-harmonized dossier structure that fixes what content belongs in each of five modules of a drug application, letting one technical package serve regulators across the ICH regions.
eCTD is the standard electronic format for pharmaceutical regulatory submissions, organizing CTD content into five modules with a machine-readable backbone so an agency can navigate an application and track every amendment across its lifecycle.
Expanded access is the FDA-authorized use of an investigational drug, biologic, or device to treat a patient outside a clinical trial, permitted only when the disease is serious or immediately life-threatening and no satisfactory alternative therapy exists.
Market Exclusivity is a statutory bar FDA enforces after approving a drug or biologic, blocking the submission or approval of competing generic, 505(b)(2), and biosimilar applications for a fixed period independent of any patent.
Marketing Authorization Application (MAA) is the dossier a sponsor files to place a medicine on the European Union market. Unlike a US NDA, it is granted by the European Commission on EMA's scientific recommendation.
New Chemical Entity Exclusivity is a five-year FDA marketing exclusivity awarded on the first approval of a drug whose active moiety has never been approved, blocking ANDA and 505(b)(2) submissions rather than merely their approval.
A New Drug Application (NDA) is the marketing application a sponsor submits to obtain FDA approval to market a new drug in the United States, carrying the complete safety, effectiveness, manufacturing, and labeling record supporting that decision.
Orange Book is FDA's published list of drug products approved as safe and effective under the Federal Food, Drug, and Cosmetic Act, paired with therapeutic equivalence codes and the patent and exclusivity information that governs generic entry.
Orphan Drug Designation is an FDA status, not an approval, granted to a drug for a disease affecting fewer than 200,000 people in the United States, carrying seven years of marketing exclusivity if the drug is later approved.
PDUFA is the US statute authorizing FDA to collect user fees from human drug and biologic sponsors, tying that revenue to negotiated review performance goals that produce the target action date known as the PDUFA date.
Pediatric exclusivity is a six-month extension of a drug's existing FDA exclusivity and patent-based approval bars, earned by completing the pediatric studies FDA specified in a Written Request under FD&C Act section 505A.
A Pediatric Investigation Plan is the EU development programme for studying a medicine in children, assessed by EMA's Paediatric Committee. Marketing authorisation applications for new medicines must report results from an agreed PIP unless a waiver or deferral applies.
Pediatric Study Plan is the FDA-agreed development document a sponsor submits before its NDA or BLA, outlining the pediatric studies it will run, their age groups and endpoints, and any deferral or waiver request.
Post-marketing commitments are studies or clinical trials a sponsor agrees in writing to conduct after FDA approval, not compelled by statute or regulation the way post-marketing requirements are, yet still reported annually until FDA agrees they are fulfilled.
Pre-Submission Meetings are formal, sponsor-requested meetings with FDA held before an application is filed, securing agency feedback on study design, evidence standards, and submission content while the plan can still change rather than after review begins.
Priority Review is an FDA marketing-application designation that shortens the agency's review-and-action target to six months, compressing the review clock only; it changes neither the evidence required nor the standard for approval.
The Purple Book is FDA's searchable list of biological products licensed under the Public Health Service Act, recording each product's licensure date, reference-product exclusivity, and biosimilarity or interchangeability status.
Refuse to File is FDA's determination, made within 60 days of receiving an NDA, that the application is not sufficiently complete to permit a substantive review, so no filing date and no review clock begin.
An RLD is the FDA-approved listed drug an ANDA relies on as its legal basis, setting the active ingredient, dosage form, strength, route, conditions of use, and labeling the generic must match.