FDA Drug Approval Process and Regulations

Title 21 Code of Federal Regulations Part 211 includes

Current Good Manufacturing Practice for Finished Pharmaceuticals.

Title 21 Code of Federal Regulations Part 210 includes

Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.

What does a class I drug recall include?

Dangerous or defective products that predictably could cause serious health problems or death

What does the pre-clinical process include?

Drug Developed by Drug Sponsor, animal tests, IND filed

Where can adverse events be reported?

FDA's MedWatch

What manufacturing information must go in the IND application?

Information pertaining to the: -composition, -manufacturer, -stability, -and controls used for manufacturing the drug substance and the drug product

Phase III clinical trials includes:

Safety Efficacy Different populations Dosages Drug combinations Needs 1000s patients

What is an Emergency Use IND?

- Allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND

what must be included in the Clinical Protocols and Investigator Information in the IND app?

-Detailed protocols for proposed clinical studies (assess whether the initial-phase trials will expose subjects to unnecessary risks). -Information on the qualifications of clinical investigators who oversee the administration of the experimental compound (assess whether they are qualified to fulfill their clinical trial duties). -Commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.

What is the approval process for a NDA?

1.) FDA meets with sponsor 2.) NDA application is filed by sponsor 3.) application review - FDA has 60 days to file the NDA 4.) Drug Label reviewed for appropriate info 5.) Facility inspection

What are the steps of the drug approval process?

1.) Pre-Clinical Process and IND Application 2.) Clinical studies/ trials 3.) NDA filed and FDA review 4.) Post-Approval Risk assessment

The goals of the NDA are to provide enough information to permit FDA reviewers to reach what key decisions:

1.) Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks. 2.) Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain. 3.) Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity

What are the pertinent centers within the FDA?

Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Toxicological Research Center for Drug Evaluation and Research

Phase II clinical trials includes:

Efficacy in disease state Safety Short term side effects Needs 100s of patients

What is included in the Animal Pharmacology and Toxicology Studies?

Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).

What does a class III drug recall include?

Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws

What does a class II drug recall include?

Products that might cause a temporary health problem, or pose only a slight threat of a serious nature

What is the purpose of the CGMP?

The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have

What is the FDA?

a consumer protection agency within the U.S. Department of Health and Human Services.

What is a drug?

any product that is intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to affect the structure or any function of the body

What is the FDA responsible for?

for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices and also responsible for the safety and security of most of our nation's food supply, all cosmetics, dietary supplements and products that give off radiation.

Phase I clinical trials includes:

frequent side effects metabolism excretion 20-80 healthy volunteers

What is the Current Good Manufacturing Practice (CGMP) ?

regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.

What does the Investigational New Drug Application include?

results of animal studies, drug composition and manufacturing process and future plans for human clinical studies

What must the sponsor do once the drug is approved?

submit periodic safety updates

What is an investigator IND?

submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed

What is a treatment IND?

submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted

What do animal tests include?

toxicity of drug. Multiple species are tested for drug safety and efficacy.