Hyman Phelps and McNamara
Training Programs
In addition to providing legal services to our clients, HPM professionals are available to speak or offer training on subjects of interest to the food, drug, and medical device industries. Examples of the type of topics we can address include:
  • FDA or other regulatory inspections
  • The drug approval process
  • The medical device clearance and approval process
  • Compliance programs
  • Advertising/promotion of FDA-regulated products
  • Medicare/Medicaid reimbursement of drugs and devices
  • Dietary supplement labeling
  • Current Good Manufacturing Practices
  • Combination (Drug/Medical Device/Biologic) products and product jurisdiction
  • FDA dispute resolution
  • Quality Systems
  • Fraud and abuse law compliance
  • Government drug pricing programs and price reporting
  • Clinical trials
  • Reporting of adverse events
  • Complaint handling
  • Prescription drug samples, and accountability
  • Prescription drug pedigrees
  • Over-the-Counter (OTC) drug regulation
  • Regulation of controlled substances and regulated chemicals
  • Regulation of laboratory-developed tests
  • Introduction of new food/supplement ingredients
  • International drug scheduling
  • Patent and non-patent marketing exclusivities (e.g., Hatch-Waxman Act)
  • FDA, FTC, and NAD regulatory requirements for foods and dietary supplements
  • Biosimilar biological product development and approval
In order for us to provide this type of training, it is not necessary for you to become a client of the firm. If you would like to arrange for a speaker, please feel free to contact any of our attorneys.

Primary Contacts:

Kurt Karst

Alan Kirschenbaum

Douglas Farquhar

Jeffrey Wasserstein

Dara Levy