Resources

A link to information pertaining to MDSAP and associated documents.

This page provides a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonized implementation of the legislation.

FDA’s Center for Drug Evaluation and Research (CDER) is large enough that it generally posts several new items to its website every day. All of those items are listed here.

FDA’s medical device review division maintains a handy page containing links to all of CDRH’s various databases, of which there are more than a dozen.

FDA’s pharmaceutical reviewers maintain a helpful list of all approved products and databases used to keep track of drug regulation information.

FDA’s webpage where it posts its most recent Warning Letters. Updated every Tuesday morning, with rare updates on other days as well.

FDA’s webpage containing weekly reports of all recalls occurring in a given week.

Is a company in trouble with FDA? You can often find out first by seeing if it’s subject to an import alert, which are posted to FDA’s website here.

FDA’s webpage for listing all new and innovative pharmaceutical products approved by the agency.

Find out when FDA has posted a new guidance document, regulation, call for comment or meeting notice by following the agency’s Federal Register page. You can also get the information a day in advance through its Special Filing page.

All of FDA’s regulatory documents, including public correspondence with FDA, is posted to the Regulations.gov website.

Lists all official FDA Guidance Documents and other regulatory guidance.

Provides education, certification, and networking opportunities to all persons involved in clinical research activities.

A knowledge-based global community of quality professionals to promote the use of techniques to improve organizational quality.

RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.