FDA May Revoke 510(k) Approvals for Transvaginal Mesh
Transvaginal mesh devices could soon be subject to more regulatory scrutiny, according to a report issued last week by the U.S. Food & Drug Administration (FDA). The report recommends that transvaginal mesh devices be re-classified as high risk, revoking their 510(k) approvals. To remain on the market, makers of transvaginal mesh devices [...]

FDA may get two more months to review new drugs
WASHINGTON (Reuters) - U.S. regulators and the drug industry want to extend by two months the deadline for the Food and Drug Administration to approve or reject new drugs.

All Approvals Are Not Created Equal
MELA's EU approval isn't nearly as important as one stateside.