Nita Garg

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FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments.  Beginning September 29, 2014, the public will have an additional thirty (30) days to provide comments on the following guidance documents:  (1) Internet/Social Media … Continue Reading

Purple Is the New Orange

Last week, the Food and Drug Administration (FDA) announced that it has published a list of licensed biological products and interchangeable biosimilars to be known as the Purple Book. The Purple Book is meant to be the biological equivalent of the pharmaceutical “Orange Book,” which is used by government agencies and healthcare providers to identify … Continue Reading

FDA Regulation of Laboratory Developed Tests on the Horizon

At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of laboratory developed tests (LDTs). Under the Food and Drug Administration Safety and Innovation Act of 2012, the FDA is required … Continue Reading

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee for the provision of support services in connection with patient referrals to the specialty pharmacy. OIG found that this per-fill fee … Continue Reading