Abbreviated New Drug Application, ANDA, NDA, New Drug Application, 505(b)(2), Biologic Licensing Application, BLA, cGMP, current Good Manufacturing Practice, Food and Drug Administration, FDA, Office of Generic Drugs, OGD, CDER, CDRH, quality control, QC, quality assurance, QA, Standard Operating Procedure, SOP, regulatory compliance, cGMP compliance, 510(k), 351(k), device, combination product, drug-device, diagnostic, 21 CFR 210, 211, Quality Systems Regulation, 21 CFR 820, ISO 13485, Drug Master File, DMF, Biologic Master File, BB-MF, Device Master File, MAF, Consent Decree, Warning Letter, Form 483, remediation, interim management, maternity coverage, solid oral dosage, topical, cream, ointment, solution, injectable, sterile, fill and finish, technical transfer, due diligence, labeling, black box warning, purification, formulation, pharmaceutical development, capsule, powder, sustained release, controlled release, cosmetic, food, fragrance, over the counter, OTC, Federal Register, Chemistry and Manufacturing Controls, CMC, pre-approval supplement, PAS, Information Request, IR, Complete Response Letter, CRL, patent, Complete Response Letter, CRL, Major Amendment, Minor Amendment, Nutraceutical, 21 CFR 111, generic, Investigational New Drug, IND, orphan drug, accelerated review, Manual of Policies and Procedures, MAPP, International Conference on Harmonization, ICH, Common Technical Document, CTD, Application Integrity Policy, AIP, Active Pharmaceutical Ingredient, API, Good Distribution Practice, GDP, Good Documentation Practice, Venture Capital, VC, inspection, pre-approval, Corrective and Preventative Action, CAPA, deviation, investigation, inspection, gene therapy, peptide, New Chemical Entity, NCE, Radio-label, method validation, Type I variation, Type II variation, Marketing Authorization Application, MAA, Drug shortage, proof of concept, POC, Clinical Trial Application, CTA, Device History File, DHF, CTX, vendor selection, drug eluting stent