Prescription and OTC Drugs

We Help Prevent Problems, Deliver Speedy Solutions

Many large corporations produce OTC and prescription drug products. However smaller businesses actually constitute a large majority of the FDA-regulated industry. Our firm works with small and medium-sized clients to assure that the impacts of all regulatory requirements are understood and that adverse impacts are lessened whenever possible, before regulations are issued.

Our Food and Drug lawyers counsel clients on the following:

• New Prescription Drug Approvals;
• Establishment Inspections;
• Laboratory Validation;
• Sterility;
• Import and Export of Drugs;
• Promotion and advertising;
• Over-the-Counter Drug Information;
• Drug Safety & Side Effects;
• Drug Preparedness and Bioterrorism Response;
• Clinical Trials;
• IRBs;
• Warning Letters; 
• Registration and Listing - Domestic and Foreign.

Helpful Links

Guidance for Drug Applications
How Drugs are Developed and Approved 
Small Business Assistance 
Import/Export of Drugs 
Drug Manufacturing 
Drug Registration 
Post-Market Requirements