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.

---

Labeling, advertising, and promotion of medical products *

USA - April 9 2012
Proper labeling of products regulated by the FDA is extremely crucial.

---

Import detention Part III: import alerts *

USA - November 8 2011
In my previous two blog posts, I discussed certain precautionary measures an importer can take to prevent an import detention by the FDA and procedures used by the FDA for detention of imported products.

---