Igor Gorlach

Foley Hoag LLP

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FDA Publishes New Guidance on Letters from Manufacturers to Health Care Providers

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

1/30/2014 - Biologics Drug Manufacturers FDA Healthcare Prescription Drugs

FDA is Soliciting Comments on Improving the Quality of ANDA Submissions

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

1/28/2014 - ANDA FDA Prescription Drugs

FDA Releases Final Guidance on the Regulation of Mobile Medical Applications

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 The guidance finalizes FDA’s 2011 draft guidance, adding numerous...more

10/1/2013 - FDA FDCA Healthcare Medical Devices Mobile Apps

The Physician Payment Sunshine Act Final Rule A Summary Of Key Provisions

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. The...more

2/8/2013 - Affordable Care Act CMS Drug Manufacturers Medicaid Medical Devices Medical Supplies Medicare Payment Records Physicians Sunshine Act Teaching Hospitals

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