FDA Issues Draft Guidance on Biosimilar Product Development Public comment sought on three documents
Mon, 02/13/2012 - 13:30
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.
“When it comes to getting new… FDA and Industry Reach Agreement in Principle on Medical Device User Fees The $595 million collected will will help reduce average total review times, says FDA
Mon, 02/06/2012 - 14:24
(FDA: Silver Spring, MD) -- The Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee… Foreign Exporters Study U.S. Food Safety LawImporter accountability and third-party certification are new challenges
Mon, 10/03/2011 - 11:27
The Food and Drug Administration’s (FDA) international program has logged nearly 75,000 hits to its web pages on the new food safety law, as foreign companies that export food to the United States scramble to learn how the law affects them.
“A… Pilot Projects to Explore Ways to Trace Sources of Foodborne IllnessSeparate studies will focus on produce and processes food
Fri, 09/09/2011 - 11:53
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has launched two new pilot projects to enhance the agency’s and industry’s ability to trace products responsible for foodborne illness outbreaks.
The Institute of Food… The ‘Teeth’ of FDA’s Food Safety LawRegistration suspensions and mandatory recalls are a couple of the new enforcement options for the FDA
Tue, 08/16/2011 - 12:46
The Food Safety Modernization Act (FSMA), signed into law by President Obama in January 2011, has been called “historic” because it puts the focus of the Food and Drug Administration (FDA) on prevention—working to ensure that unsafe foods are not… FDA Asks for Public Comment on Pathway to Lower-Risk Medical DevicesAgency continues to seek improvements to the device review process
Wed, 08/03/2011 - 12:17
(FDA: Silver Spring, MD) -- The FDA has announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical… FDA Issues Draft Guidance on Premarket Notification for Medical DevicesGuidance clarifies the kinds of changes that trigger the need for a new submission
Mon, 08/01/2011 - 15:00
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
The 510(k) process is the… FDA, Federal Partners Develop Tools for Food-Emergency ReadinessWeb-based food-related emergency exercises help stakeholders gauge their response to potential disasters
Wed, 07/27/2011 - 12:50
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) and federal partners has released the Food Related Emergency Exercise Boxed (FREE-B) set, a web-based collection of scenarios that will help government regulators, public… FDA to Set Production Standards for Safer Fruit and VegetablesFarmers and consumers invited to comment on proposed produce safety regulation
Wed, 07/13/2011 - 06:00
As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?”
The United States has had its own headline-grabbing outbreaks from contaminated… FDA Unveils Global Strategy for Safety, Quality of Imported ProductsStrategy calls for coalitions of international regulators, increased data sharing
Wed, 06/22/2011 - 11:31
(FDA: Washington) -- The U.S. Food and Drug Administration (FDA) unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global…
