News & Analysis as of

Administrative Agency Health Science, Computers & Technology

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

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

Professional Regulatory Alert: No Loyalty Program for Drugs: Court Confirms Prohibition on Pharmacy Inducements

by Field Law on

The Alberta Court of Appeal recently confirmed that professional regulators have significant discretion to implement rules and policies intended to protect the public interest. Specifically, rules and policies may include the...more

PTAB Declines Request to Review Method of Treating Lymphoma Claim

A Patent Trial and Appeal Board (PTAB) panel declined to institute an inter partes review (IPR) of a claim directed to a method for treating low grade B-cell non-Hodgkin’s lymphoma. The challenged method required patients to...more

FDA Simplifies and Clarifies Expanded Access Program

by Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

by Foley & Lardner LLP on

In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

FDA Launches New Tool For Accessing Drug Adverse Event Information

by Hogan Lovells on

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D....more

Working Together: FDA Releases Final Guidance on Interoperability

by Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

FDA Issues Final Guidance For Medical Device Exchange of Patient Information

The Food and Drug Administration (FDA) issued guidance yesterday (September 6, 2017) entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices,” which is intended to “assist...more

FDA Recalls St. Jude Medical Pacemakers for Cybersecurity Patches

The Food and Drug Administration (FDA) has issued a recall of 465,000 St. Jude Medical pacemakers in order to push a mandatory firmware patch of vulnerabilities in six types of radio controlled cardiac pacemakers....more

Publication of Final Regulations on Patent Linkage and Term Restoration

by Smart & Biggar on

On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more

Drones Delivering Medical Supplies in East Africa but not in U.S.

Residents in remote areas of Tanzania and Rwanda in East Africa are receiving medical supplies through the use of drones, far surpassing similar efforts in the U.S., according to Robert Graboyes, a senior research fellow at...more

FDA Seizes Stem Cell Therapy—A First of Many?

by Hogan Lovells on

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the...more

FDA Announces New Device User Fees with Significant Increases for Some Submissions

by Hogan Lovells on

On August 29, 2017, FDA published a Federal Register notice with the device user fees for the Agency’s Fiscal Year (FY) 2018, which begins on October 1, 2017. Due to statutory increases, inflation adjustments and target...more

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

by Knobbe Martens on

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

Minnesota Patent Litigation Wrap-Up – July 2017

by Fish & Richardson on

This post continues our monthly summary of patent litigation in the District of Minnesota, including short summaries of substantive orders issued in pending cases. In July 2017, there were three notable decisions for...more

Baker Administration and Legislature Debate Range of Health Care Proposals

Massachusetts policymakers are currently engaged in a robust debate over several proposals aimed at lowering health care costs in the Commonwealth. The House of Representatives rejected a set of MassHealth reforms that the...more

Health Alert (Australia) 24 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 18 July 2017 - Ms Shahin Tavassoli v Bupa Aged Care Mosman [2017] FWC 3200 - Application for an unfair dismissal remedy. The...more

921 Results
|
View per page
Page: of 37
Cybersecurity

Follow Administrative Agency Updates on:

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.