News & Analysis as of

Medical Devices Pharmaceutical Industry The United States Food and Drug Administration

AGG Food and Drug Newsletter - July 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Don’t give medical device makers more time before disclosing product woes

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republican leaders are expected to make a series of changes to the healthcare legislation released Thursday as they scramble to gain the support of at least 50 lawmakers in a showdown vote scheduled for later this...more

FDA Requires Reprocessing Validation Data for Certain Reusable Devices

by Hogan Lovells on

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

Filling in the Gaps on Medical Device Cybersecurity

by Hogan Lovells on

Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...more

Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

by Hogan Lovells on

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

by Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. Please see full...more

21st Century Cures: What's In the Box?

by Mark Mansour on

One of FDA’s most important tasks in the coming months will be the implementation of the 1,000 page long 21st Century Cures bill, enacted last year. We have assembled a quick, bullet-pointed summary of some of the major...more

Patent Term Extension for Drugs Not Limited to New Chemical Entities

by Pepper Hamilton LLP on

Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more

Greatbatch Medical Recalls Hip-Replacement Instrument Which Has Potential To Infect Patients

The U.S. Food and Drug Administration has issued a Class 1 recall for a handheld instrument used during hip-replacement surgery. The device failed sterility tests....more

St. Jude Medical On Hot Seat for Cybersecurity Flaws in Home Monitoring System

The Food and Drug Administration (FDA) recently issued a warning letter to St. Jude Medical, alleging that it failed to properly investigate issues with the batteries in its defibrillator implants and for failing to fix the...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

The Importance of Aligning Your Regulatory and IP Strategies

by Mark Mansour on

One of the least discussed but potentially most important part of the drug and device approval process is the smooth functioning of the IP and the regulatory strategies. It is natural to focus first on the IP issues,...more

Anaphylaxis Possible Risk of Recalled EpiPen Auto-Injector, Epi-Pen Jr Auto-Injector

A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need....more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

173 Results
|
View per page
Page: of 7
Cybersecurity

"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.