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Mobile apps: the FDA publishes its final guidance on regulating mobile medical apps

Canada, USA - October 4 2013 Canadian mobile medical app developers will be interested in the FDA's recent guidance on the regulation mobile medical apps in the United States. On…

Mobile apps: the FDA is on its path of enforcement actions

USA - July 24 2013 Mobile health care is one of the most booming industries worldwide, with a strong potential for growth and an excellent financial prognosis. No…

FDA's final rule for combination products

USA - January 29 2013 On January 22, 2013, the Food and Drug Administration (FDA) issued a final rule on current good manufacturing practice (CGMP) requirements applicable…

Establishment registration: FDA's new importer disclosure policy burdens foreign establishments

USA - October 24 2012 A foreign establishment cannot register with the FDA for the fiscal year 2013 without disclosing the names, addresses, and phone numbers of “all known importers” of its device in the United States.

Another victory for FDA, bigger warning for regulated industry

USA - July 12 2012 On July 2, British drug maker GlaxoSmithKline agreed to plead guilty and pay a $3 billion fine for its off-label marketing of three drugs and for its failure to comply with the FDA’s post-marketing reporting requirements for one of its drugs.