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 ...

On May 10, 2012, a US Food and Drug Administration (FDA) advisory committee voted in support of the use of tenofovir-emtricitabine for HIV prevention. 1 If the FDA, which is scheduled to make its decision by June 15, adopts the committee's recommendations, tenofoviremtricitabine will become the first antiretroviral drug to be approved as pre-exposure prophylaxis (PrEP) for the prevention of HIV...

We find that pre-announcement implied volatility spreads and options trading activity are abnormally elevated can predict Food Drug Administration (FDA) announcement date stock returns. The effect is more pronounced in firms with higher levels of information asymmetry lower-quality corporate governance suggesting some traders informed advance the details affect price impact FDA news. provide fi...

To meet its public mandate, the US Food and Drug Administration (FDA) collected studies on the potential health hazards of eating or drinking cloned food products. Based on an earlier National Academy of Sciences study that, on closer analysis, was not nearly as sanguine, the FDA's report found no evidence of a health risk from the public's ingestion of cloned food products. This article analyz...

The Food and Drug Administration (FDA) is reopening until February 12, 1999, the comment period for the draft guidance for industry entitled ‘‘Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics’’ that appeared in the Federal Register of October 14, 1998 (63 FR 55067). FDA is taking this action in response to a request for an extension. DATES: Written comments on the d...

INTRODUCTION The resistance of gram-positive pathogens to currently available antibiotics has increased at an alarming rate, while the development of new effective agents has not kept pace.1 In response to this critical global concern, the Generating Antibiotic Incentives Now Act, part of the Food and Drug Administration Safety and Innovation Act, was signed into law in July 2012 to expedite th...

The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued. DATES: This rule is effective August 12, 2013. FOR FURTHER INFORMATION CONTACT: Eri...

Abbreviations: BRAD: US EPA Biopesticides Registration Action Document, EA: Environmental Assessment, EC: European Commission, EPA: US Environmental Protection Agency, FAO: U.N. Food and Agriculture Organization, FDA: US Food and Drug Administration, FFDCA: Federal Food, Drug and Cosmetic Act, FIFRA: Federal Insecticide, Fungicide and Rodenticide Act, GE: genetically engineered, MRID: Master Re...

The establishment in 1995 of the World Trade Organization (WTO) and the adoption of international trade agreements pertaining to food regulation currently have a significant impact on domestic regulatory policies established by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and other agencies responsible for protecting consumers and ensuring the safety of the...

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA sta...