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  • Article

    Congressional Panels Take Steps To Speed Patient Access To Medical Innovation

    On January 27, 2015, the House Energy and Commerce Committee released its "21st Century Cures Act" discussion draft, the product of a year-long, bipartisan effort by the Committee to accelerate the pace of medical cures in the United States.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Connecticut's $39 Million Award A Bitter Bill For Pharmacy To Swallow

    Connecticut AG William Tong obtained a judgment in his favor in his office's lawsuit against Assured Rx, LLC ("Assured")...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Cozen O'Connor
    Cozen O'Connor
Article

Controlled Substances Act Regulation Legislation Approved by Senate

The Senate recently approved an amended version of S. 483, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.
United StatesFood, Drugs, Healthcare, Life Sciences
Reed Smith
Reed Smith
  • Article

    Controlled Substances Treatment/Regulation Bills Clear Senate Judiciary Committee

    The Senate Judiciary Committee approved two bipartisan bills on February 11, 2016 that are intended to address abuse of opioid and other controlled substances and clarify the regulation of controlled substances.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    COOL Meat Labels Formally Repealed

    On March 2, 2016, USDA formally issued a final rule amending the controversial country-of-origin labeling ("COOL") rule to remove beef and pork products from the requirement to indicate where animals were born...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    CVM Amends Animal Drug Rules To Reflect Withdrawal And Approvals

    In the July 2, 2014 Federal Register, FDA's Center for Veterinary Medicine issued several notices related to approval actions and a withdrawal.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    D.C. Issues Emergency Rule For Telemedicine Reimbursement

    The emergency rules will remain in effect until October 21, 2016, unless superseded by a Notice of Final Rulemaking.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    DEA Finalizes Hydrocodone Regulations

    Hydrocodone with acetaminophen has been the most widely prescribed drug since 2007, with more than 135 million prescriptions written in 2012.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    DEA Issues Final Rule On Safe, Secure Disposal Of Controlled Substances

    The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for "ultimate users" to dispose of unused or unwanted pharmaceutical controlled substances.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Deadline For Stakeholders' Comments On Performance Check Of EU General Food Law Regulation

    In December 2013, the European Commission initiated a fitness check of EU food legislation in order to identify burdens, inconsistencies, gaps, and ineffective measures, referred to as the REFIT.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    DOJ False Claims "Working Group" Update

    CYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS)...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Sheppard
    Sheppard
  • Article

    Draft Guidance Promises Major Changes In New Chemical Entity Exclusivity Provisions

    FDA issued draft guidance in February that significantly departs from its historical interpretation of the five-year New Chemical Entity exclusivity provision.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    Drug Companies Are Reminded - FDA Is Following Facebook

    The FDA’s Office of Prescription Drug Promotion has warned a Swiss drug company about statements the company made on its Facebook page.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    EMA Organizes Orphan Medicines Workshop

    The EMA has announced it is organizing a workshop on December 7, 2015, to discuss the approach that should be followed by medicine developers to demonstrate the significant benefit of orphan medicines over existing treatments
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA Releases Practical Guidance On Access-To-Documents Requests

    On November 24, 2014, EMA released a practical guide detailing the process for requesting access to unpublished documents held by the Agency.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EMA To Allow Use Of Non-EEA Authorized Comparator In Clinical Studies

    The effective date of the revised guideline is April 30, 2015. Applicants may, however, apply some or all provisions of this guideline beginning October 29, 2014.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    Environmental Groups Sue FDA To Ban Perchlorate In Food Packaging

    On March 31, 2016, a coalition of six public health and environmental organizations filed suit in the Ninth Circuit to force the FDA to act on its 2014 petition to ban perchlorate in food packaging.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    EPA Finds Common Pesticide Threatens Beehives

    The U.S. Environmental Protection Agency ("EPA") announced that neonicotinoid, a commonly used insecticide, harms beehives when it comes into contact with certain crops that attract pollinators.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    European Commission Approves Samsung Bioepis And Biogen's Aflibercept Biosimilar

    On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    False Advertising Claims & The First Amendment

    Over on Reed Smith's AdLaw by Request blog, attorney Caroline Klocko discusses the U.S. Court of Appeals for the District of Columbia Circuit's January 30th ruling...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Showing 501–520 of 14474 results

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