Links

European Parliament Approves Bill to Increase Clinical Trial Transparency

Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with EU ministers and passed by...

Read More

DARPA LAUNCHES BIOLOGICAL TECHNOLOGIES OFFICE

“DARPA has created a new division, the Biological Technologies Office (BTO), to explore the increasingly dynamic intersection of biology and the physical sciences. Its goals are to harness the power of biological systems by applying the...

Read More

NEJM — New FDA Breakthrough-Drug Category — Implications for Patients

New FDA Breakthrough-Drug Category — Implications for Patients Jonathan J. Darrow, S.J.D., J.D., M.B.A., Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H. N Engl J Med 2014; 370:1252-1258 March 27, 2014 DOI: 10.1056/NEJMhle1311493 http://www.nejm.org/doi/full/10.1056/NEJMhle1311493?query=TOC...

Read More

openFDA — New opportunity for app developers and others

openFDA is a new initiative in the Food and Drug Administration’s Office of Informatics and Technology Innovation spearheaded by FDA’s Chief Health Informatics Officer. openFDA will offer easy access to FDA public data.  On launch,...

Read More

Humanitarian Device Exemption (HDE): Questions and Answers – Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: March 18, 2014 You should submit comments and suggestions regarding this draft document within 90 days of publication in...

Read More

Administrative Procedures for CLIA Categorization – Guidance for Industry and Food and Drug Administration Staff

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070762.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery On February 28, 1992, the Department of Health and Human Services (DHHS) published laboratory standards regulations (57 FR 7002) implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. 263a).  The implementing...

Read More

Good advice

Professor Ralph Nash, one of the most distinguished scholars of government contracting law, provides this list of “Mistakes in Contract Administration.” I didn’t read the contract! I didn’t try to understand the three R’s –...

Read More

NIH opens research hospital to outside scientists

Ten projects that will enable non-government researchers to conduct clinical research at the National Institutes of Health’s Clinical Center in Bethesda, Md. were announced today. Through these three-year, renewable awards of up to $500,000...

Read More

Florida Hospital System Agrees to Pay the Government $85 Million to Settle Allegations of Improper Financial Relationships with Referring Physicians

Halifax Hospital Medical Center and Halifax Staffing Inc. (Halifax), a hospital system based in the Daytona Beach, Fla., area, have agreed to pay $85 million to resolve allegations that they violated the False Claims...

Read More

Jury Convicts All Seven Defendants in $97 Million Medicare Fraud Scheme

A federal jury in Houston today convicted two owners of a former Houston mental health care company, Spectrum Care P.A. (Spectrum), several of its employees and the owners of certain Houston group care homes...

Read More