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What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

Obama FDA’s Parting Shot On Off-Label Promotion And The First Amendment

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part...more

Potential Repeal of Medical Device Tax

With the upcoming Republican-dominated Presidency and Congress in 2017, the Affordable Care Act, or at least parts of it, look to be on the chopping block. One of the changes that may be forthcoming is a repeal of the 2.3%...more

Beyond the Eleventh Hour: FDA Prepares to Finalize Intended Use Amendments Despite Midnight Rule Relief Act

On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what...more

The New FDA: Product Development, Pricing and Beyond - Part 2

What impact will the incoming Trump administration have on the 2017 health care and life sciences regulatory outlook? In this two-part podcast, The New HHS: Tom Price and Value-Based Health Care and The New FDA: Product...more

The New HHS: Tom Price and Value-Based Health Care - Part 1

What impact will the incoming Trump administration have on the 2017 health care and life sciences regulatory outlook? In this two-part podcast, The New HHS: Tom Price and Value-Based Health Care and The New FDA: Product...more

OFAC Expands Iran-Related Authorizations for Medicine, Medical Devices and Agricultural Commodities

On December 23, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) issued a Final Rule amending the Iranian Transactions and Sanctions Regulations, 31 C.F.R. Part 560 (ITSR) to expand the...more

The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions

Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...more

U.S. Senate committee rips drug makers for predatory price-gouging

Congress must stop Big Pharma predators from ripping off American consumers by acting like hedge funds, buying up decades-old, off-patent drugs and jacking up prices on long-standing “gold standard” prescription medications,...more

Precision Medicine - Obama’s Health Care Legacy

As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed...more

20 states, U.S. take aim at collusion claims, soaring prices for generic drugs

If there ever were naïve wishes that parts of Big Pharma might work in more enlightened ways for patients, the attorney generals in 20 states and federal prosecutors, have dashed optimism about “white hat” drug makers. Led by...more

Governor Cuomo announces US$650 million life sciences funding initiative

On December 19, 2016, New York Governor Andrew Cuomo announced a US$650 million life sciences initiative aimed at creating an industry and research "cluster" in New York state. The life sciences sector, generally defined as...more

21st Century Cures Act offers array of holiday gifts to healthcare providers

The 21st Century Cures Act, a rare beneficiary of broad bipartisan support, has been signed into law by President Barack Obama. The law has received much public acclaim for its $4.8 billion in new funding over the next...more

Health Update - December 2016

Balancing Gene Therapy’s Promise and Price - Editor’s Note: Exciting advances in science have led to developing treatment breakthroughs, such as gene scripting therapies, that could represent the first potential cures...more

21st Century Cures Act – Provisions Relating to Digital Health

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

21st Century Cures Act – Provisions to Promote Drug Development

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

21st Century Cures Act – Provisions Relating to Medical Device Innovation

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

21st Century Cures Act – Provisions Relating to Regulation of Clinical Research

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

21st Century Cures: Not Just a Biomed Bill

The 21st Century Cures Act signed into law on December 13, 2016 is gaining significant attention as landmark legislation promoting medical innovation. But the massive Cures Act goes much further and includes some relief...more

President Obama Signs the 21st Century Cures Act Into Law

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

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

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

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

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

Senate Passes 21st Century Cures Act

Last week, the Senate passed the 21st Century Cures Act, a $6.3 billion medical research bill. The bill authorizes billions of dollars to the National Institutes of Health (“NIH”). ...more

Client Alert on amendments to the Law on medicines - New Amendments to the Law “On Medical Products” and Other New Developments

On 14 October 2016 the President of the Republic of Azerbaijan signed Amendments to the Law On Medical Products (the ”Amendment Law”). The Amendment Law has introduced into the Law On Medical Products the following new...more

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