Useful Links

LinkDescription 
BSINational standards body of the United Kingdom.
21 CFR Title 21 Part 820Most up to date version of CFR – Code of Federal Regulations Title 21 Part 820 Quality System Regulation.
Medical Device DirectiveMost recent version of the MDD along with supporting guidances.
International Organization for StandardizationISO creates documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.
Regulatory Affairs Professionals Society (RAPS)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.
American Society for Quality (ASQ)A knowledge-based global community of quality professionals to promote the use of techniques to improve organizational quality.
The Society of Clinical Research Associates, Inc. (SOCRA)Provides education, certification, and networking opportunities to all persons involved in clinical research activities.
Guidance DatabaseLists all official FDA Guidance Documents and other regulatory guidance. 
Regulations.govAll of FDA's regulatory documents, including public correspondence with FDA, is posted to the Regulations.gov website.
Federal RegisterFind 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.
Drug InnovationFDA's webpage for listing all new and innovative pharmaceutical products approved by the agency.
Import AlertsIs 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.
Enforcement ReportsFDA's webpage containing weekly reports of all recalls occurring in a given week.
FDA Warning LettersFDA's webpage where it posts its most recent Warning Letters. Updated every Tuesday morning, with rare updates on other days as well.
Drug Approvals and DatabasesFDA's pharmaceutical reviewers maintain a helpful list of all approved products and databases used to keep track of drug regulation information.
Medical Device DatabasesFDA'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.
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.

Page last updated on September 1, 2017. Is a link on this page broken? Are we missing an important website? Email us at info@alvamed.com.