The National Institutes of Health (NIH) seeks comments on its draft Genomic Data Sharing (GDS) Policy that outlines the responsibilities of investigators and institutions when submitting nonhuman and human genomic data to NIH. The GDS Policy also describes the use of controlledaccess data and provides expectations regarding intellectual property. Comments must be submitted within 60 days of the September 20, 2013, Federal Register publication date.
The U.S. Food and Drug Administration schedules a public workshop titled “Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases,” organized by the Center for Devices and Radiological Health and Office of Orphan Products Development. It will be held in conjunction with the Center for Drug Evaluation and Research’s workshop, “Complex Issues in Developing Drug and Biological Products for Rare Diseases.” Among the topics planned for discussion at the January 8, 2014, workshop are (i) current clinical practices, (ii) specialty practice areas, (iii) clinical trials, (iv) device-related issues for diagnostic devices, and (v) advancing development. Those wishing to participate should register by December 6. The workshop will also be available via streaming Webcast.
The U.S. Food and Drug Administration (FDA) slates a public workshop titled “Complex Issues in Developing Drug and Biological Products for Rare Diseases,” for January 6-7, 2014. FDA hopes that input from the workshop will help develop a strategic plan to encourage and accelerate the development of new therapies for rare diseases. Discussion will include (i) “complex issues in clinical trials for developing drug and biological products for rare diseases, including endpoint development and selection, use of surrogate endpoints and the accelerated approval pathway, clinical trial design, conduct and analysis, safety considerations, and dose selection”; and (ii) “ways to encourage and accelerate the development of new therapies for pediatric rare diseases.” Participants should register by December 20. The workshop will also be available via streaming Webcast.
The U.S. Food and Drug Administration (FDA) announces the availability of draft guidance for industry titled “Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.” The document is intended to describe which parameters should be assessed in toxicology studies for investigational new drug applications, new drug applications and biologics license applications ”regulated by the Center for Drug Evaluation and Research to determine the potential for a drug to disrupt the endocrine system.” It also discusses factors to consider when determining the need for additional studies to characterize a drug’s potential endocrine disruptor properties. Comments are requested by November 19, 2013.
The U.S. Food and Drug Administration seeks comments on the estimated reporting burdens of an information collection arising from the Food, Drug, and Cosmetic Act requirement that all new drug application applicants and those filing an amendment or supplement submit “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” Comments are requested by October 17, 2013.