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Life Sciences › Pharmaceutical Industry › Product Recalls

Searcy Denney Scarola Barnhart & Shipley

Cancer and Medication: Advocating for Yourself and Your Health

Searcy Denney Scarola Barnhart & Shipley on

Unfortunately, the risk of a cancer diagnosis is a very real concern with many common (and not-so-common) medications. While drug companies have a legal duty to ensure that their medications are safe, these companies don’t...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

Stikeman Elliott LLP on

On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Stikeman Elliott LLP

Palmer v. Teva Canada Ltd.: Court of Appeal Confirms No Compensation for Risk “In the Air”

Stikeman Elliott LLP on

In Palmer v. Teva Canada Limited, the Ontario Court of Appeal upheld the lower court’s decision to deny certification of a proposed product liability class action seeking damages for the alleged increased risk of being...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

American Conference Institute (ACI) on

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Epstein Becker & Green

Unpacking Averages: Analyzing the Relationship Between MDRs and Recalls

Epstein Becker & Green on

Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we...more

Nelson Mullins Riley & Scarborough LLP

Potential Nitrosamine Contamination Results in Another Voluntary Pharmaceutical Recall

Nelson Mullins Riley & Scarborough LLP on

On March 22, 2023, at the request of the U.S. Food and Drug Administration (“FDA”), Ascend Laboratories LLC. (“Ascend”) issued a voluntary nationwide recall of certain lots of Dabigatran Etexilate Capsules, a blood thinner...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Arnall Golden Gregory LLP

Get Back to Where You Once Belonged: FDA Issues Final Guidance on Initiating Voluntary Recall

Arnall Golden Gregory LLP on

In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials...more

Console and Associates, P.C.

Product Recall Notice: Exactech Knee and Ankle Devices

Console and Associates, P.C. on

Recently, the medical device manufacturer Exactech, Inc. announced a recall of more than 140,000 knee and ankle implants over concerns that the product packaging failed to protect the devices from potentially harmful exposure...more

Knobbe Martens

Two Drugs Recalled Due to Manufacturing Issues

Knobbe Martens on

Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products. ...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

American Conference Institute (ACI) on

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Hogan Lovells

China’s drug regulator seeks comments on updated drug recalls regulation

Hogan Lovells on

On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) proposed an...more

Hogan Lovells

FDA issues final guidance for public warnings and notification of recalls

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or...more

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