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HTMLCMS Bringing Star Ratings to Home Health
Ari J. Markenson; Duane Morris LLP;
Legal Alert/Article
January 23, 2015, previously published on December 12, 2014
The Centers for Medicare and Medicaid Services (“CMS”) issued a fact sheet on December 11th, 2014, discussing its intention to issue star ratings for Medicare certified home health agencies. The star ratings would be live in 2015.

 

HTMLFDA to Undergo Changes As Recommendations for Re-Alignment are Released Amid "Unparalleled Challenges" Posed By Product Complexity and Globalization
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
More than a year after its creation, the Program Alignment Group (PAG) issued final recommendations on how to realign the FDA, releasing six distinct "Action Plans" in a bid to improve the agency’s structure and regulation.

 

HTMLNinth Circuit Clarifies Scope of Mass Action Federal Jurisdiction and Removal
Karin Bohmholdt, Benjamin S. Kurtz, Ginger Pigott; Greenberg Traurig, LLP;
Legal Alert/Article
January 23, 2015, previously published on November 26, 2014
In Corber v. Xanodyne Pharm., Inc., and Romo v. Teva Pharmaceuticals USA, Inc., &under;&under; F.3d &under;&under; (Case No. 13-56306 and 13-56310), 2014 WL 6436154 (9th Cir. Nov. 18, 2014), the Ninth Circuit, sitting en banc, held that a petition to coordinate multiple actions under California...

 

HTMLFDA Puts Final Touches on Inspection Guidance to Provide More Clarity and Respond to Industry Concerns, While Maintaining Strong Stance on Its Photography Authority
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
In finalizing a policy aimed at ensuring companies aren’t able to hide problems during inspections, the agency provided the industry with additional details regarding facility inspections in a bid to reduce confusion, adding descriptive material and preserving robust rules about photography.

 

HTMLFDA Attempts to Increase Security of Mobile Devices in Midst of Growing Threat of Cyberattacks with Guidance Focusing on Security-By-Design, While Some Say Focus Should Be on Data
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
As the regulator attempts to play catch-up with the fast-evolving world of connected devices by issuing guidance, critics fear the regulations fail to fully address the complexity of cyber threats.

 

HTML7th Circuit Clarifies FCA Fraud Standard
Philip H. Lebowitz; Duane Morris LLP;
Legal Alert/Article
January 23, 2015, previously published on December 5, 2014
In an opinion openly skeptical of a relator’s knowledge, the 7th Circuit Court of Appeals recently affirmed the dismissal of False Claims Act claims against a Chicago pharmacy brought by a former employee of the pharmacy. The principal claims in the case, nadyor v. Ukrainian Village Pharmacy,...

 

HTMLThe IMPACT ACT of 2014 - New Enforcement and Oversight for Hospice Providers
Ari J. Markenson; Duane Morris LLP;
Legal Alert/Article
January 23, 2015, previously published on December 8, 2014
The IMPACT Act of 2014 (“IMPACT”) was signed into law on October 6, 2014. It includes two significant enforcement and oversight changes for Medicare hospice providers among other post-acute care policy changes.

 

HTMLFda Issues Final Guidance on Discerning Device Recalls from Market Withdrawals Related to Medical Device Enhancements in Apparent Bid to Appease Industry Concern Over Draft Being Overly Broad, Lacking in Term Definitions
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
The regulator put out the final guidance document to ensure companies are able to clearly distinguish a recall from a market withdrawal after the draft version sparked concern and confusion throughout the industry.

 

HTMLClinical Trial Sponsors Can Be Liable For Inadequate Consent Forms
Philip H. Lebowitz; Duane Morris LLP;
Legal Alert/Article
January 23, 2015, previously published on December 12, 2014
Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so. Federal...

 

HTMLOIG 2015 Work Plan - Hospice
Ari J. Markenson; Duane Morris LLP;
Legal Alert/Article
January 22, 2015, previously published on November 21, 2014
Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015. The work plan provides stakeholders with a road map to the OIG’s activities in the coming year as they relate to its enforcement priorities and issues it will...

 


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