…principal changes that are not fee-related. FDAGA 2008 proposed several new requirements and authorities applicable to foods, including establishment of a food safety plan, safety standards for fresh produce, periodic…

By David B. Clissold & Carrie S. Martin – Last Friday, FDA issued two new draft guidance documents regarding clinical trial designs: Guidance for Industry: Adaptive Design Clinical Trials for Drugs…

…some cancer patients.  The REMS consists of a medication guide, communication plan, and elements to assure safe use (“ETASU”).  The medication guide is to be provided at retail/hospital outpatient pharmacies…

…down to the district court for further proceedings.  Since pharmaceutical and medical device companies rarely plan reimbursement strategies without outside consultants, this case is important to companies and consultants alike….

By William T. Koustas – Last week, FDA announced the approval of Onsolis (fentanyl buccal soluble film) with a substantial Risk Evaluation and Mitigation Strategy (“REMS”), as well as a…

…National List of Allowed and Prohibited Substances (National List). In recent years, on several occasions, consumers have brought actions against companies for marketing organic foods, notably infant formula, alleging that…

…provide a streamlined approach for selling otherwise unapproved products intended to alleviate the national emergency. Today’s blog post describes a separate, but related, FDA initiative to alleviate companies’ postmarketing reporting…

…“Pregnancy” labeling subsection, prescription drug labeling would be required to contain pregnancy exposure registry information (if applicable), a general statement about the background risk of fetal developmental abnormalities, a fetal…

…year, Democratic Presidential Candidate John Edwards proposed such a system as part of his health care plan.  In addition, the World Health Organization mentioned prizes as a complementary mechanism to…

…of postmarking cases from the AERS database, medical literature, and post-approval clinical trial data.  The Agency determined that the number of AEs was likely higher than Public Citizen’s estimates, and…

…patient). This concept can be particularly important for medical products that treat disease states primarily defined by patient perception/complaint. PROs can be used in a wide range of manners in…

…and “The Marketing Pendulum Has Swung,” which will focus on case studies analyzing off-label civil and criminal enforcement activity. A stellar cast of presenters will share their knowledge and provide…

…order would impose administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances on the manufacture, distribution, possession, importation, and exportation of, and research and conduct…

…published in the Federal Register are to be immediately withdrawn, and then reviewed by a Presidential appointee or designee. Lastly, regulations that have been published in the Federal Register but…

…is there mention of possible referral to the Office of Chief Counsel or Office of Criminal Investigations for review of more egregious alleged misconduct, although several of the categories of…