Mark M. Yacura, Partner

Drug and Biologic Products

  • Represented and advised companies on drug approval strategies for abbreviated new drug applications, 505(b)(1) and 505(b)(2) new drug applications, and suitability petitions, as well as Orphan Drug, patent term, and new drug exclusivities and user fees matters.
  • Attended FDA pre-IND, end of Phase II, pre-NDA, and other official meetings to negotiate and advocate for client's drug testing plan for approval.
  • Advised clients and negotiated with the FDA to obtain Abbreviated New Drug Application (ANDA) approval for complex generics, as well as for generics mimicking an innovator drug that had been voluntarily removed from the market for reasons other than safety.
  • Reviewed labels, promotional labeling websites, and advertising of prescription and over-the-counter (OTC) drug products to advise clients on compliance with the "intended use" aspects of the Food, Drug, and Cosmetic Act (FDCA) and related laws. Advised clients on "off-label" promotion issues based on scientific literature.
  • Advised companies sponsoring drug companies, clinical trial service companies (CRO), institutional review boards (IRB), and clinical investigators on compliance and enforcement actions regarding good clinical practices and investigator fraud issues.
  • Assisted clients on FDA and DEA inspections of their manufacturing facilities, including responses to Form 483 observations and compliance requirements.
  • Represented clients in response to official FDA Warning Letters, Untitled Letters, and Consent Decrees concerning unapproved new drug, misbranding, adulteration and good manufacturing practice violation allegations. Represented clients whose products are subject to border stops and seizure actions.
  • Advised clients on product life cycle issues, including approval of new dosage forms for existing products and new uses for existing products.
  • Counseled clients on various forms of exclusivities, including new drug exclusivities and Waxman/Hatch patent exclusivities, 30-month stays, and Orange Book issues.
  • Assisted companies marketing metered dose inhalers and propellant issues.
  • Assisted clients regarding Citizen Petitions on a variety of subjects including the status of "old" generally recognized as safe and effective (GRASE) and Drug Efficacy Study Implementation (DESI) drugs and requesting FDA to refund improper user fee assessments.
  • Represented clients on Prescription Drug Marketing Act requirements regarding promotions of their prescription drugs.
  • Assisted clients in obtaining monographs in the United States Pharmacopeia (USP) for their drug ingredients and drug products.
  • Represented makers of homeopathic drug products regarding label claims and FDA inspections.
  • Assisted clients with obtaining release of detained products at the U.S. borders.
  • Counseled medical gas companies regarding drug and device claims for their combination product.
  • Assisted clients regarding various DEA registration, drug shortage, rescheduling, and alleged compliance/enforcement violations.
  • Advised clients regarding various drug reimbursement and rebate issues before the Center for Medicare & Medicaid Services (CMS), as well as fraud, abuse, and antitrust issues.
  • Performed due diligence for banks, private equity, or venture capital groups on regulatory health of companies who were targets of a merger or acquisition, or targets for inclusion in an investor portfolio.
  • Expertised the FDA regulatory sections of S-1 and various securities statements.