The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Drugmakers planning to assign clinical trial participants to a separate arm of the study based on baseline monitoring must report those plans to the European Medicines Agency, including which factors — called covariates — they plan to rely on to make those assignments. Read More
For the first time, the European Medicines Agency has produced a guideline on clinical trial design for drugmakers developing targeted products to treat lupus — an effort by the EMA to encourage more companies to target the underserved disease. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance issued this week. Read More
Clinical trial sites using software to obtain patients’ informed consent remotely should make sure that data is stored securely, the FDA says in Friday draft guidance on handling electronic informed consents. Read More
Clinical investigators in India could face up to five years in jail for studies that violate the country’s clinical trial regulations, under draft legislation released in late December by the Department of Health and Family Welfare. The prospect could further hinder India’s clinical trials industry, one expert says. Read More
The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing. Read More
Mobile health programs can unburden clinical trial sponsors and investigators by streamlining procedures, eliminating unnecessary activities and reducing site visits, according to GlaxoSmithKline and Medidata. Read More
Clinicians, bioethicists and regulators disagree over whether or not some patients in Ebola drug trials should be given placebos, and the debate is pitting the FDA against some international organizations.