Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators.

The US Food and drug administration: drug information resource for formulary recommendations.

BACKGROUND The U.S. Food and Drug Administration (FDA) is the regulatory agency responsible for approving all pharmaceutical products marketed in the United States. While the FDA does not conduct research for developing pharmaceutical products, the agency does review all of the scientific evidence that a pharmaceutical sponsor submits and ensures that it demonstrates U.S. regulatory standards f...

Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

The US Food and Drug Administration and probiotics: regulatory categorization.

Probiotics are living microorganisms that, when consumed, have the potential to confer a beneficial health effect. Unfortunately for purveyors of probiotic products, the system of regulation delineated in the Food, Drug, and Cosmetic Act is anything but "one size fits all." How a probiotic product is used or is intended to be used will govern the regulatory category or categories that the US Fo...

The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.

Sponsors of human drug and biologic products subject to an investigational new drug (IND) application are required to distribute expedited safety reports of serious and unexpected suspected adverse reactions to participating investigators and the FDA to assure the protection of human subjects participating in clinical trials. On September 29, 2010, the FDA issued a final rule amending its regul...

Investigational new drugs: export requirements for unapproved new drug products. Final rule.

The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the ...