…provide a template and a model REMS.  Violations of REMS are subject to stiff civil monetary penalties.  Under FDAAA, the penalties may not exceed $250,000 per violation, or $1 million…

By Kurt R. Karst –       The Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) share some common ground.  All three…

…more immediate and aggressive enforcement action by FDA.  Against traditional pharmaceutical manufacturers, FDA has, in its armamentarium, civil (e.g., TRO, seizure) and criminal (FD&C Act prosecution) judicial actions that can…

…of the earlier enforcement actions relating to HIPAA, the disclosure of PHI was unintentional and not made for personal gain. It is also notable given it occurred in a clinical…

…program antikickback statute (“AKS”, 42 USC 1320a-7b(b)), the OIG recognized that the program operates entirely outside of all Federal health care programs, meaning that patients obtain the product without using…

…by the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) challenging a “first in the nation” Safe Drug Disposal Ordinance…

…in China, and Carmen M. Shepard, Senior Vice President of Global Policy and Regulatory Counsel at Mylan Inc., who will provide industry perspective on these issues. Ms. Shepard will also…

…Sciences, Inc. (the factual and procedural background is summarized here and here). In short, the relators allege the company made misrepresentations to FDA that led to product approval and ultimately…

…and place all food safety responsibilities in a single federal agency, announced on September 28th that he would propose an amendment to sunset all food safety agencies by 2010.  Sen….

…inspection, authorize the issuance of subpoenas, provide whistleblower protection, and provide for enhanced criminal and civil penalties for certain prohibited acts with respect to foods.  The bill would also authorize…

By Jeffrey N. Gibbs & Allyson B. Mullen – A new article published on Medical Device and Diagnostic Industry’s (MDDI) website by Hyman, Phelps & McNamara, P.C.’s Jeff Gibbs, Allyson…

…to FDA patient engagement information regarding the design and conduct of a medical device clinical study.” What would be the potential benefits if companies prospectively design medical device clinical studies…

…The Executive Order includes objectives to bolster and coordinate Federal investment in biotechnology and biomanufacturing, and to improve and expand on domestic biomanufacturing production capacity and processes while also accelerating…

…Spinal Plating Systems, Orthopedic Non-Spinal Metallic Bone Screws and Washers, Magnetic Resonance Receive-Only Coils, Cutaneous Electrodes for Recording Purposes, Conventional Foley Catheters, Fracture Fixation Plates, Surgical Sutures, Denture Base Resin,…

FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC)….