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Medical Devices › Cancer › Prescription Drugs

Searcy Denney Scarola Barnhart & Shipley

10 Important Facts About Filing a Depo-Provera Lawsuit

Searcy Denney Scarola Barnhart & Shipley on

If you have questions about filing a Depo-Provera lawsuit, you are not alone. As awareness of the link between Depo-Provera and intracranial meningioma continues to grow, we are continuing to hear from more women and family...more

Wilson Sonsini Goodrich & Rosati

FDA Outlines Considerations for the Development and Labeling of Companion Diagnostics for Use with a Specific Group or Class of...

Wilson Sonsini Goodrich & Rosati on

Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more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

Mintz - Health Care Viewpoints

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

Mintz - Health Care Viewpoints on

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

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