Upcoming Regulation 2023/607 Transitional Provision Deadlines for MDR
On March 15, 2023, citing the impact of the COVID-19 pandemic, the lack of designated notified bodies and the associated over-capacities, and the imminent threat of significant shortages of necessary medical devices available on the market, the EU set forth Regulation 2023/607, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for […]
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.
Regulations.gov
All of FDA’s regulatory documents, including public correspondence with FDA, is posted to the Regulations.gov website.
