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Pharmaceutical Industry › Food and Drug Administration (FDA) › Congressional Review Act

Mintz - Health Care Viewpoints

Mintz IRA Update — Opposition to the Use of March-In Rights to Lower Drug Prices

Mintz - Health Care Viewpoints on

In our previous Mintz IRA Update, we covered the Biden administration’s proposal exploring the use of “march-in rights” granted under the Bayh-Doyle Act (the “Act”) to seize pharmaceutical patents if the administration...more

Hogan Lovells

New OMB review process could impede FDA issuance of guidance documents

Hogan Lovells on

Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents. ...more

Mintz - Health Care Viewpoints

Beyond the Eleventh Hour: FDA Prepares to Finalize Intended Use Amendments Despite Midnight Rule Relief Act

Mintz - Health Care Viewpoints on

On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what...more

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