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Statutory Basis For Label Carve-Outs - Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use where the reference listed drug (RLD) has multiple indications, not all of

On January 4, 2021, Mark C. Christie was sworn in as FERC’s newest Commissioner.

With a new Administration moving into Washington D.C. amidst tension and confusion, immigration compliance remains top of mind for employers. I know that because I hear from H.R.

With the availability of COVID-19 vaccinations and anticipated push to vaccinate the general public in the coming months, it is expected that many employers will mandate that their workers obtain a vaccination either prior to returning to the workplace or as a requirement to remain employed.

On January 12, 2021, the Department of Health and Human Services issued yet another Federal Register notice announcing that Persons that Entered the Over the Counter drug market to supply hand sanitizers during the COVID-19 Public Health Emergency will not be subject to the over the counter Monog

Calling all pet parents! At least 20 companies currently provide pet insurance, but there has traditionally been little regulatory supervision surrounding these products — until now.

Seyfarth Synopsis: Effective January 26, 2021, all international passengers (with minor exceptions) traveling by air must provide a negative COVID-19 viral test to enter the U.S.

On January 1, 2021, the United States Senate joined the House of Representatives in overriding President Trump’s veto, and the National Defense Authorization Act (NDAA) became law. The NDAA was passed chiefly to authorize appropriations for military activities of the Department of Defense.

As COVID-19 vaccines are becoming more accessible to the general public, employers may be considering a mandatory administration of the vaccine in an effort to protect their employees, customers, and patients during the pandemic.

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