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Life Sciences › Food and Drug Administration (FDA) › 21st Century Cures Initiative

Hogan Lovells

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

Hogan Lovells on

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

McDermott Will & Emery

21st Century Cures: Modernizing Public and Private Research

McDermott Will & Emery on

The 21st Century Cures Act, signed into law by President Obama on December 13, encourages biomedical research investment and facilitates innovation review and approval processes. Through National Institutes of Health (NIH)...more

Morgan Lewis

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

Morgan Lewis on

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more

Latham & Watkins LLP

President Obama Signs the 21st Century Cures Act Into Law

Latham & Watkins LLP on

The act creates faster, more flexible FDA drug and biologic review, new drug and device approval pathways, increases FDA funding, and reduces EHR administrative burdens. On December 13, 2016, President Obama signed into...more

Mintz - Health Care Viewpoints

President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

Mintz - Health Care Viewpoints on

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product...more

Knobbe Martens

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

Skadden, Arps, Slate, Meagher & Flom LLP on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Morgan Lewis

21st Century Cures Act and Medical Device Regulatory Pathways

Morgan Lewis on

These seven key provisions will affect the premarket requirements for medical devices. The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign the bill into law....more

Morgan Lewis

The 21st Century Cures Act and Its Effect on Digital Health

Morgan Lewis on

New legislation includes a broad regulatory exemption for medical software. On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new...more

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