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FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

The President’s Budget and Shifting Policy on Prescription Drugs

On February 12, the Trump administration released the President’s Budget (or “the Budget”), outlining spending priorities for FY 2019. The Budget—though an important annual milestone and barometer of the administration’s...more

FDA Amends Regulations For Data From Foreign And Domestic Investigation For Medical Devices

On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...more

FDA Issues Draft Guidance for Obtaining Qualified Infectious Disease Product Designation Under the GAIN Act

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on obtaining "Qualified Infectious Disease Product" (QIDP) designation for antibacterial and antifungal drug candidates intended to treat serious or...more

FDA Issues New Compounding Guidance

In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more

Rx IP Update - January 2018

by Smart & Biggar on

Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more

FDA proposes rule to codify existing guidance on supervisory review of CDRH decisions

by Hogan Lovells on

On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal agency supervisory review of certain decisions related to devices regulated...more

Medicare 340B Drug Payment Policy Survives Legal Challenge; Hospitals Say, It's Not Over

by Baker Ober Health Law on

A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

by Hogan Lovells on

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

FDA Proposes to Delay Off-Label “Intended Use” Rule

by Reed Smith on

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

FDA 2017 Year in Review

by McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

Corporate Law & Governance Update - January 2018

by McDermott Will & Emery on

Technology-Driven Disruption - Recent news stories and governance publications serve to underscore the challenge to health systems posed by innovation-based business model disruption. Health care boards will be expected to...more

Stanford Medical Center Seeks FAA Approval for Blood Delivery by Drone

Stanford Medical Center (Stanford) is pursuing a new concept in the health care world—blood delivery to hospitals by drones. Currently, Stanford is seeking the Federal Aviation Administration’s (FAA) approval for this type of...more

ML Strategies Outlook: Health Care

“We’re going to have to get back next year at entitlement reform, which is how you tackle the debt and the deficit” Paul Ryan, Speaker of the House. Happy New Year!?! - 2017 was an eventful year for health care, and...more

Rx IP Update - December 2017

by Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Health Update - December 2017

Part 1: Megatrends Reinventing How Patients Think - Editor’s Note: In a recent webinar for PharmaVOICE, Manatt Health revealed the megatrends reinventing the life sciences industry—and how they relate to new thinking by...more

Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents

by Hogan Lovells on

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and digital health products to bring FDA...more

FDA Issues Guidance on Digital Health

by Stinson Leonard Street on

The Food and Drug Administration (FDA) issued two guidance documents last week clarifying its approach to certain health-related software in response to the addition of Section 520(o) to the Food, Drug and Cosmetic Act, which...more

Canada releases proposed amendments to Regulations governing patented medicines pricing

by Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

FDA Releases Stem Cell Guidance Documents

by Foley & Lardner LLP on

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more

Ready to Release a New Pharmaceutical? What to Think About When Selecting Your Drug Name

by Foley & Lardner LLP on

Pharmaceutical name clearance in the United States can be complicated. This post aims to provide insight into the regulatory safety review process and the trademark registration process for candidate drug names. This...more

Data Privacy + Cybersecurity Insider - November 2017 #2

by Robinson & Cole LLP on

Michigan Governor Rick Snyder has signed into law the Cyber Civilian Corps Act, which established the Michigan Cyber Civilian Corps, dubbed MiC3. The corps has been in existence for three years but not statutorily deployed. ...more

The Impact of the New Connecticut Budget on the Health Care Industry

The bipartisan state budget became law yesterday (the “Budget Act”). While Governor Malloy vetoed a provision requiring supplemental payments to hospitals, the Budget Act includes numerous other provisions affecting the...more

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

by Knobbe Martens on

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more

Rx IP Update - October 2017

by Smart & Biggar on

Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

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