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MoFo Life Sciences

FDA Issues New Draft Guidance On Demonstrating Substantial Evidence Of Effectiveness With One Clinical Investigation And...

MoFo Life Sciences on

On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more

Arnall Golden Gregory LLP

A Guide to FDA’s Evolving Interpretation of How Sponsors Can Demonstrate Substantial Evidence of Effectiveness for Human Drug and...

A new drug’s effectiveness must be established by “substantial evidence,” which is defined in 505(d) of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA has interpreted the law as generally requiring at least two...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - February 2018

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

Knobbe Martens

FDA Announces Plans for Alternative Clearance Pathway

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Arnall Golden Gregory LLP

FDA Says Sharing Medical Product Information is Caring, to an Extent

FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...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FDA Issues Draft Guidance Addressing Communications with Payors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On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers.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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