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Life Sciences › Right to Try

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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On 23 July, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

Hogan Lovells

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

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On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Mintz - Health Care Viewpoints

GAO Report Sheds Light on Drug Manufacturers’ Expanded Access Programs

Mintz - Health Care Viewpoints on

Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more

Wilson Sonsini Goodrich & Rosati

FDA Launches Expanded Access Experimental Cancer Drug Project

Wilson Sonsini Goodrich & Rosati on

In the U.S., patient access to investigational cancer drugs—outside of clinical trials licensed by the U.S. Food and Drug Administration (FDA)—has historically proven insurmountable for most patients for at least the...more

Morgan Lewis

FDA Continues to Facilitate Expanded Access

Morgan Lewis on

Over the last few months, FDA has continued its efforts to encourage and facilitate the use of the agency’s Expanded Access Program (EAP). This follows other FDA EAP actions, including its announcement of program...more

Sunstein LLP

July 2018 IP Update: The Right to Try Act: A New Avenue for Use of Experimental Drugs

Sunstein LLP on

On May 30, President Trump signed the Right to Try Act. The Act authorizes the use of experimental drugs without pre-approval or oversight by the Food and Drug Administration. Both the patient and the drug must meet certain...more

Goodwin

Expanded Access Policy Disclosure and Federal Right-to-Try Law

Goodwin on

This client alert provides background on two recent developments related to patient access to investigational therapies outside of the clinical trial setting: expanded access and right-to-try. First, we discuss a fairly new...more

Troutman Pepper

Right to Try Legislation: Worthwhile or Window Dressing?

Troutman Pepper on

"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more

Hogan Lovells

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

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Right-to-try laws and the future of access to investigational treatments - The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws,...more

Arnall Golden Gregory LLP

Right-to-Try or Right to Ask?

Arnall Golden Gregory LLP on

Recently, the American Society of Clinical Oncology (ASCO), a prominent medical organization, announced that it does not support so called “right-to-try” laws. Right-to-try legislation, which has now gained support in 33...more

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