This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover products for specific disease categories (hemophilia, rare diseases, and retinal disorders), and three of which address manufacturing and clinical study design issues related to gene therapy: chemistry, manufacturing and control (CMC) information in
On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs).
Hogan Lovells has issued a Sponsored Research Alert outlining a Notice of Proposed Rulemaking (NPRM) issued by the U.S. Department of Health and Human Services (HHS) that seeks to amend the U.S. Government’s policy on protection of human research subjects. As the Alert describes: The NPRM would substantially change, in several respects, the regulatory framework with which universities and research
This week the Federal Communications Commission’s (FCC’s) CONNECT2HEALTHFCC Task Force, a group formed in March 2014 that is focused on using broadband deployment to accelerate the adoption of advanced healthcare technologies, is joining more than 400 other public and private organizations in recognizing National Health IT Week (NHIT week). NHIT week is a series of
In a 20 June 2014 draft guidance, the Food and Drug Administration (FDA or Agency) proposed that, once the guidance is finalized, the Agency would refrain from enforcement of all regulatory requirements for a subset of hardware and software that transfers, stores, converts, formats, and displays medical device data or medical imaging data, which would
In the last month, the Food and Drug Administration (FDA) undertook two new steps related to Health IT in the United States While the FDA’s involvement in this area of technology remains very controversial, both projects sought to enhance collaboration with the Health IT industry. FDASIA Workshop First, on May 13-15, 2014, the FDA, Federal Communications Commission (FCC),
In the first ever FTC-litigated challenge to a hospital system’s acquisition of a physician group, the U.S. District Court for Idaho ruled in favor of the plaintiffs (the FTC, Idaho Attorney General, and St. Alphonsus, a competing hospital system). The plaintiffs challenged St. Luke’s Health System’s acquisition of the Saltzer Medical Group, a 41-physician multi-specialty
The FTC announced that it will host a one-day workshop on December 10, 2013, in Washington, DC, and is requesting public comments by March 1, 2014, on the topic of competition issues relating to biologics and follow-on biologics. The Notice of the workshop and call for comments, which was published in the Federal Register, indicates
On August 13, 2013, the Food and Drug Administration (“FDA”) issued final guidance on design principles for medical devices using radio frequency (“RF”) wireless technology that are implanted or worn on the body and that are intended for use in locations such as hospitals, homes, clinics, and clinical laboratories. This guidance comes as the FCC
In a significant decision with implications beyond the healthcare industry, the D.C. District Court upheld a ruling by the U.S. Department of Labor’s Administrative Review Board (ARB) deeming three Pennsylvania hospitals government subcontractors subject to the Office of Federal Contract Compliance Programs’ (OFCCP) jurisdiction. UPMC Braddock v. Harris, No. 1:09-cv-01210-PLF (D.D.C. Mar. 30, 2013).