ADVERTISING AND PROMOTION ANIMAL DRUGS AND FEEDS CONSUMER PRODUCT SAFETY COMMISSION CONTROLLED SUBSTANCES CORPORATE TRANSACTIONS DRUG SUPPLY CHAIN AND DISTRIBUTION ENFORCEMENT FOODS AND DIETARY SUPPLEMENTS HEALTH CARE IN VITRO DIAGNOSTIC DEVICES MEDICAL DEVICES OTC DRUGS AND COSMETICS PRESCRIPTION DRUGS AND BIOLOGICS PRODUCT JURISDICTION AND COMBINATION PRODUCTS TISSUE PRODUCTS TOBACCO TRAINING PROGRAMS FIRM NEWS FIRM PUBLICATIONS   Prescription Drugs and Biologics   Product Approval The firm has developed a reputation for its expertise in new drug development. Working with scientific and medical experts, we assist companies in preparing and filing full new drug applications (both 505(b)(1) and 505(b)(2) NDAs) and abbreviated new drug applications (ANDAs), biologic license applications (BLAs), including biosimilar BLAs, and investigational new drug (IND) applications. We advise on: Statutory and regulatory standards Approval strategies, from the investigational stage through options such as fast track breakthrough therapy, accelerated approval and treatment INDs Application process, including meetings, internal appeals, user fee issues, advisory committee presentations, Drug Enforcement Administration (DEA) scheduling, and administrative proceedings Agreements with clinical investigators, contract research organizations, and data management organizations Post-approval support, including supplemental NDAs and agency actions based on new information Rx-OTC switch applications Risk Evaluation and Mitigation Strategies (REMS) Hatch-Waxman lifecycle management strategies Exclusivity HPM has expertise in every aspect of FDA-related marketing protection requirements, including: New drug biologic exclusivity ANDA exclusivity Patent extension Orphan drug exclusivity Pediatric use exclusivity Citizen petitions Compliance and Post-Marketing Requirements HPM has broad experience in issues relating to FDA regulation of marketed drug products, including: Establishment Registration and Product Listing Adverse Drug Reports Labeling Changes Supplemental Applications Applications Integrity Policy Bioresearch Monitoring Prescription Drug Marketing Act, Drug Supply Chain Security Act/Drug Sampling/Wholesaler Requirements Good Manufacturing Practice (GMP) Compliance Drug Master Files Compounding To view other enforcement matters frequently handled by our attorneys, click on Enforcement. Primary Contacts: Josephine Torrente David Clissold Kurt Karst Frank Sasinowski Robert Dormer Alan Kirschenbaum (medical imaging drugs) Michelle Butler Douglas Farquhar John Gilbert, Jr. Larry Houck Jeffrey Wasserstein Anne Walsh Karla Palmer Mark Schwartz Firm Publications