CDER – What’s New?

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.

Medical Device Databases

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.

Drug Approvals and Databases

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

FDA Warning Letters

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

Enforcement Reports

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

Import Alerts

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.

Drug Innovation

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

Federal Register

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.