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Life Sciences › Draft Guidance › Investigational New Drug Application (IND)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

Hogan Lovells

FDA invites comments on Expanded Access to Investigational Drugs guidance

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a revised version of the draft guidance “Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers,” which includes recommendations for...more

Akin Gump Strauss Hauer & Feld LLP

FDA Issues Draft Guidance on Equity, Diversity and Individual Sponsor Financial Ability Considerations in Charging for...

Akin Gump Strauss Hauer & Feld LLP on

On August 23, 2022, the United States Food and Drug Administration (FDA or the “Agency”) published the revised draft guidance “Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry” (the...more

Hogan Lovells

FDA offers new guidance on charging for investigational drugs

Hogan Lovells on

On Monday, the U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to FAQs about FDA’s policies for charging...more

MoFo Life Sciences

FDA Issues Draft Guidance On Human Gene Therapy Products Incorporating Human Genome Editing

MoFo Life Sciences on

On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell...more

Goodwin

Safety First! Much-Anticipated FDA Draft Guidance Provides Additional Advice on the Development of Human Genome Editing Products

Goodwin on

Last week the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, that addresses key considerations for the development of gene therapy...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2016

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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