Home > Legal Library > Advanced Search > Search Results









Join Matindale-Hubbell Connected



Search Results (1094)

  
Documents on Antitrust & Trade Regulation, Pharmaceuticals, Internet & E-Commerce
 

View Page: 1  2  3  4  5  6  7  8  9  10  Next  >>
Show: results per page
Sort by:
Sponsored Results

HTMLFDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities
Duane Morris LLP;
Legal Alert/Article
February 26, 2015, previously published on December 9, 2014
On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

 

HTMLFDA Proposes Three Studies on Direct-To-Consumer Prescription Drug Ads in a Bid to Better Understand the Impact of Ad Exposure Frequency, Spousal Influence and Risk Understanding
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The agency announced three proposed studies on how people view direct-to-consumer advertising, as it continues to assess factors that influence assessments of risks and benefits in a bid to ensure its regulations adequately protect public health.

 

HTMLIn An Unusual Move, The FDA Takes Issue With The Accuracy Of Sciecure’s Studies In A Warning Letter Over Sales Promotion Material For The Company’s Sleeping Pill
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
In addition to criticizing the pharmaceutical company for leaving out risk information from its sales materials and making unsupported superiority claims, the regulator unusually disputed the accuracy of the sources Sciecure used to bolster its assertions.

 

HTMLThe Department of Health and Human Services Proposes Tougher Reporting Rules in a Bid to Increase Clinical Trial Transparency
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The DHHS is seeking to expand the scope of information on clinical trials that must be submitted to the NIH’s online data set of experiments in the midst of ongoing concerns that too many trial results are withheld.

 

HTMLOffice of Inspector General’s 2015 Work Plan Shows Agency Will Examine Medical Device Security, FDA’s Regulation
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
February 25, 2015, previously published on November 2014
The Department of Health and Human Services’ watchdog agency released a 2015 work plan that calls for federal auditors to assess medical device cybersecurity amid intensifying scrutiny in the area, as well as areas that may be in need of some revamping by the FDA.

 

HTMLPublic Justice and AAJ Contest Dismissal of Big-Pharma Fraud Case
Jordan Elias; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
November 10, 2014, previously published on October 21, 2014
Public Justice (represented by Lieff Cabraser) and the American Association for Justice today filed an amicus brief in the U.S. Court of Appeals for the Second Circuit urging the reinstatement of civil RICO claims that Sanofi-Aventis profited from a scheme to market and sell its antibiotic Ketek by...

 

HTMLLouisiana Federal Judge Dramatically Reduces $9 Billion Punitive Damage Award To $37 Million
Sutherland Asbill Brennan LLP;
Legal Alert/Article
November 5, 2014, previously published on October 30, 2014
On Monday, U.S. District Judge Rebecca Doherty (Western District of Louisiana) cut a total punitive damage award from $9 billion to $36.875 million, an award 244 times smaller than the jury had determined. The case involved the first trial in an MDL involving the potentially unsafe effects of a...

 

HTMLCompetition Bureau Releases Updated IP Guidelines
Jonathan Bitran, Dominic Thérien; McCarthy Tétrault LLP;
Legal Alert/Article
October 28, 2014, previously published on October 20, 2014
On September 18, 2014, the Competition Bureau (Bureau) released updated Intellectual Property Enforcement Guidelines (IPEGs). These IPEGs are an update of the original guidelines released in 2000 and result from recent consultations; the Bureau has announced that it will soon conduct another...

 

HTMLFDA Fast-Tracking Experimental Drugs
McDonald Hopkins LLC;
Legal Alert/Article
October 22, 2014, previously published on October 17, 2014
The development of a pharmaceutical drug is a slow, deliberate process, and it can take years of back-and-forth between scientists and health officials before medicine makes it to the market.

 

HTMLDEA Releases Final Rule on Disposal of Controlled Substances
Duane Morris LLP;
Legal Alert/Article
October 3, 2014, previously published on September 26, 2014
On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the Secure and Responsible Drug Disposal Act of 2010 (the "Disposal Act"), and...

 


View Page: 1  2  3  4  5  6  7  8  9  10  Next  >>