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Manufacturers › Draft Guidance › Investigational New Drug Application (IND)

Mintz - Health Care Viewpoints

FDA Rolls Out Innovative New Designation Programs in Response to Congressional Mandates

Mintz - Health Care Viewpoints on

Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more

Sheppard Mullin Richter & Hampton LLP

Charging for Investigational Drugs Under an IND Questions and Answers, Draft Guidance for Industry, August 2022

Sheppard Mullin Richter & Hampton LLP on

Providing further clarification to drug manufacturers about specific costs that can be charged for investigational drugs used in clinical and expanded access trials...more

King & Spalding

FDA Issues Draft Guidance Addressing Communications with Payors

King & Spalding on

On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more

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