The FDA is a large federal consumer protection and regulatory agency within the U.S. Department of Health and Human Services. The FDA is responsible for assuring the safety and efficacy of drugs for human and veterinary use, biological products, medical devices and products that emit radiation, cosmetics, and food safety. In addition, the FDA regulates the manufacturing and marketing of tobacco products.
The FDA employs close to 15,000 people. The largest FDA offices are located in Maryland, close to Washington, DC. There are also regional offices across the United States and offices in China, India, Europe, the Middle East, and Latin America.
If you have not already done so, you should take a look at the FDA website, www.fda.gov ( not fda.org or fda.com). It may take some practice to find what you want but FDA.gov is an very useful reference for physicians, scientists and researchers, industry employees, and consumers. If you are new to industry, you might want to start with the pages called "FDA Basics for Industry". (You can find these links under Resources).
In addition, if you are a newcomer to the Pharmaceutical Industry or if you are taking on a new role that includes direct FDA interactions, you might find a useful introductory course on the modules called CDERLearn on the FDA website. CDERLearn provides educational tutorials offered by the Center for Drug Evaluation and Research (CDER). Current topics include topics such as " Best Practices for Communication Between FDA and IND Sponsors During Drug Development" and a tutorial on "Electronic Common Technical Document (eCTD)" and another presentation called "Engaging with the FDA During New Drug Development."
If you work in Discovery or Development, or Safety Reporting, or Medical Affairs, almost everything you do will be guided by FDA regulations. If you are a physician in industry, most of your interactions with the FDA will be guided by your Regulatory Affairs staff. You may interact directly with the FDA if you are involved in the submission of an IND, or an NDA. One interaction you do not want is a meeting with the Agency because your company or one of your products has “gotten itself in trouble” in some way.
FDA regulations are not the only rules that industry must follow. In 1990, decision was made to try to “harmonize” drug development regulations in the USA, Canada, Europe and Japan. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was formed. The ICH has developed its own set of Guidelines for Safety and Efficacy topics as well as the MedDRA (Medical Dictionary for Regulatory Activities) and the Common Technical Document (CTD) format for drug applications. The FDA maintains its own regulations but also follows the ICH Guidelines as well. If you are involved in developing a drug that will be submitted for marketing in countries outside the US, you will become acquainted with the ICH. In some ways, ICH has harmonized the drug development process, in others, it has added a new layer of rules and regulations.
The FDA is divided into Offices and Centers. If you work in industry, you are most likely to interact with one or more of the the following:
CDER (Center for Drug Evaluation and Research)*;
CBER (Center for Biologics Evaluation and Research);
CDRH (Center for Devices and Radiologic Health);
OPDP (The Office of Prescription Drug Promotion);
The Office of Biostatistics;
The Office of Clinical Pharmacology
The Office of Generic Drugs
*CDER is the largest Center in the FDA. CDER has an Office of New Drugs that
is further divided into 6 Offices for Drug Evaluation. Like all large agencies, CDER
undergoes reorganization from time to time. At present, these are the Offices and
Divisions that take the lead in the NDA review process.
The Office of Drug Evaluation I (ODE I) includes the
Division of Cardiovascular and Renal Products (DCARP)
Division of Neurologic Products (DNP)
Division of Psychiatric Products (DPP)
The Office of Drug Evaluation II (ODE II) includes the
Division of Anesthesia, Analgesia, and Addiction Products (DAAAP)
Division of Metabolism and Endocrinology products (DMEP)
Division of Pulmonary, Allergy, and Rheumatology Products (DPAR)
The Office of Drug Evaluation III (ODE III)
Division of Dermatology and Dental Products
Division of Gastroenterology and Inborn Errors Products
Division of Bone, Reproductive, and Urologic Products
The Office of Drug Evaluation IV (ODE IV)
Division of Nonprescription Drug Products (DNDP)
Division of Medical Imaging Products (DMIP)
Division of Pediatric and Maternal Health (DPMH)
The Office of Antimicrobial Products
The Office of Hematology and Oncology Products
The Office of Surveillance and Epidemiology (formerly Drug Safety)
FDA Guidance Documents
The FDA issues Guidance Documents to present “ their current thinking on a topic.” The documents usually include a disclaimer that “they do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.” Nevertheless, in my experience, if a Guidance document is available for a topic relevant to your work, it behooves you to review it carefully and follow it as much as possible or be prepared to discuss why you are using a different approach.
Guidance document are introduced as “draft” documents to allow time for review and comment. Theoretically these drafts are supposed to be finalized after review and discussion but some ‘Draft” guidances remain as drafts for years.
There is no easy way of knowing which topics have been addressed in a FDA Guidance document without searching the list of Guidances or consulting your regulatory advisor.
There is a list of Guidance Documents in the Resource Section under the Guidance tab.