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The intercenter agreements (ICAs) governing how combination and single-entity products are assigned to FDA centers have become "incomplete statements" due to a slew of emerging new products and the large volume of jurisdictional decisions the agency has made in recent years, the FDA said.
The FDA is taking steps to introduce more regulatory flexibility into postmarket reviews to get industry’s support for the agency’s Quality by Design (QbD) initiative, officials said.
The European Commission and the European Medicines Agency (EMEA) have issued a joint document setting priorities for implementing new safeguards for drugs intended for use in children, anticipated to take effect in January 2007.
Regulations aimed at protecting IT operations and edata aren't going away and companies should evolve their compliance environments into cost-effective, sustainable programs, according to experts speaking at a Sept. 13 webinar, "The Evolution of Controls for Compliance -- The Next Phase: Controls Automation & Monitoring."
With more than 55 million Americans identified as edata breach victims, 2005 may go down in history as the "Year of the Breach," said health industry privacy attorney Renee Martin at the Thirteenth Annual HIPAA Summit in Washington, D.C., Sept. 26.
Device firms that send manufacturing operations and clinical trials overseas may save time and money but will also need to exercise more vigilance over their suppliers, experts say.
Merck could see a boost in Gardasil prescriptions if an effort in the Michigan state legislature requiring all girls entering sixth grade to receive vaccinations against the sexually-transmitted human papillomavirus (HPV) is successful.
Under new regulations passed by the European Parliament, drug companies that research the safety and efficacy of their products in children will get a six-month patent extension.
California’s proposed prescription drug program will likely undermine future innovations by wrongly imposing artificial price controls, the drug industry says.
Starting in January 2007, every medical device and pharmaceutical manufacturer, as well as other importers and exporters, will need a special security certificate to move products freely through the EU market.