We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design and analysis of safety studies and the potential use of biomarkers in various stages of medicinal development. Read More
The FDA released guidance on the International Council for Harmonization’s good clinical practice guidelines and its addendum on advances in clinical trial design. Read More
In its first ever annual report, the Office of Pharmaceutical Quality highlighted its main accomplishments in 2017 and noted it faced major challenges with more than 100 of its 1,300 officers deployed for inspections in the aftermaths of Hurricanes Harvey, Irma and Maria. Read More
Commenting on FDA’s planned patient-focused drug development guidance, industry stakeholders said the agency needs to clarify how it will incorporate patient experience data into specific stages of development. Read More
Additionally, 21 member states impose penalties for falsification across the manufacturing supply chain, including manufacturing, distribution, brokering, import, export and sale at a distance. Read More
Researchers at the FDA and the Centers for Medicare and Medicaid Services are considering whether a cell-based influenza vaccine might be more effective than the egg-based vaccine that did not prove very effective against this year’s H3N2 flu strain, according to Commissioner Scott Gottlieb. Read More
The Justice Department is creating a task force to combat the opioid crisis and plans to file a Statement of Interest in multidistrict litigation against distributors and manufacturers of opioids, according to Attorney General Jeff Sessions. Read More
The U.S. Department of Justice filed a complaint against Patient Care America, a Pompano Beach, Florida compounding pharmacy, claiming the firm made illegal payments to secure prescriptions for drugs reimbursed by TRICARE — the federally-funded health care program for military members and their families. Read More
In another blow to Allergan’s efforts to retain exclusivity for its dry-eye drug Restasis, the U.S. Patent Trials and Appeals Board said Allergan’s transfer of the patents to the St. Regis Mohawk tribe last year conferred only “illusory rights” and denied the company’s motion to terminate Mylan’s challenge to six of its patents. Read More
HHS Secretary Alex Azar said the FDA plans to expand the use of medication-assisted treatments for opioid addiction and will soon issue two new guidances on the topic. Read More