PHARMA SECTOR TO SEE USFDA CHECKS

PHARMA SECTOR TO SEE MORE USFDA CHECKS 

Indian pharmaceutical sector could see an increased number of inspection/ re-inspections of their by the U.S. Food & Drug Administration (USFDA) to clear the overall backlog, India Ratings and Research (Ind-Fa) said 

U.S. drug regulator FDA  had postponed facility inspections from April 2020 due to the COVID-19 lockdown

Would impact new approvals and clearance for facilities

Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services

 

Headquarters in unincorporated White Oak, Maryland

 

Number of field locations across the United States in addition to international locations in China, India, Europe, Middle East, and Latin America

FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services

 

FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act; FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs 

FDA frequently works with other federal agencies, including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection, and Consumer Product Safety Commission

FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling

 

Office of Regulatory Affairs is considered the "eyes and ears" of the agency, conducting the vast majority of the FDA's work in the field

Consumer Safety Officers are the individuals who inspect production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items 

Office of Criminal Investigations was established in 1991 to investigate criminal cases 

FDA's research efforts include the areas of biologics, medical devices, drugs, women's health, toxicology, food safety and applied nutrition, and veterinary medicine 

Center for Biologics Evaluation and Research is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents, include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products 

Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices

Center for Veterinary Medicine (CVM) is a center of the FDA that regulates food additives and drugs that are given to animals

FDA also has had the authority to regulate tobacco products

 

FDA's Office of Prescription Drug Promotion reviews and regulates prescription drug advertising and promotion through surveillance activities and issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission.