Federal Food, Drug, and Cosmetic Act (FD&C Act): Primary federal law governing pharmaceutical companies, covering drug safety, efficacy, manufacturing, and marketing requirements
Hatch-Waxman Act: Regulates generic drug approval process and patent term extensions for pharmaceutical products
Public Health Service Act: Governs biological products and provides framework for public health programs
Securities Acts: Securities Act of 1933 and Exchange Act of 1934 governing public offerings and trading of securities, relevant if planning to go public
State Corporation Laws: State-specific laws governing corporate formation, governance, and operations (e.g., Delaware General Corporation Law)
FDA Regulations (21 CFR): Comprehensive regulations covering drug development, manufacturing, testing, and marketing requirements
Good Manufacturing Practice (GMP): Standards for pharmaceutical manufacturing processes, quality control, and facility maintenance
Drug Supply Chain Security Act: Requirements for track-and-trace systems in pharmaceutical supply chain
Controlled Substances Act: Federal regulations for handling, storing, and distributing controlled substances
DEA Registration Requirements: Registration and compliance requirements for handling controlled substances
Patent Act: Federal law governing protection of pharmaceutical innovations and intellectual property
Trade Secrets Protection: Laws protecting confidential business information and proprietary manufacturing processes
OSHA Regulations: Workplace safety and health requirements specific to pharmaceutical manufacturing and research
Environmental Protection Laws: EPA regulations governing waste disposal, emissions, and environmental impact of pharmaceutical operations
State Pharmaceutical Licensing: State-specific requirements for pharmaceutical company licensing and operations
