The Food and Drug Administration (FDA) issued a new guidance document on Dear Health Care Provider (DHCP) letters, titled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” DHCP...more
The Food and Drug Administration (FDA) announced the establishment of a public docket for comments regarding Abbreviated New Drug Application (ANDA) submissions to the agency. FDA is specifically looking for input regarding...more
On September 23, 2013, the Food and Drug Administration (FDA) published the final guidance on its regulation of “mobile medical applications (or apps).” The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more
On February 1, 2013, Centers for Medicare and Medicaid Services (CMS) published the long-awaited Physician Payment Sunshine Act (Sunshine Act) Final Rule, implementing Section 1128G of the Social Security Act.