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.
The Therapeutic Goods Administration is updating its guidance on the collection, maintenance and disclosure of commercially confident information, focusing on eight principles agency staff should consider in disclosing submitted information. Read More
Failing to communicate with a sponsor in a timely manner or collect data from clinical sites may be signs that a CRO isn’t doing its job — and a sign that it’s time for the sponsor to find a new partner, experts say. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
The European Medicines Agency is planning a series of May meetings with industry to unveil the process it plans to use to determine whether clinical trial data is considered confidential under its new transparency rules or whether it must be disclosed. Read More
Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More
AbbVie has dropped two lawsuits against the EMA over the agency’s plans to disclose clinical trial data for its rheumatoid arthritis drug Humira (adalimumab), clearing a major hurdle for the EMA’s transparency initiative. Read More