• Regulatory NewsRegulatory News

    Biologics Exclusivity Still Central in Trade Talk Debate

    The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history. While the US Trade Representative (USTR) and the biopharmaceutical industry have publicly called for a 12-year exclusivity period, Politico reports that some industry lobbyists are tempering their expectations. Background Among the 12 parties to TPP, the United States is the on...
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    Should You Pursue a Master's Degree or a Regulatory Affairs Certificate?

    There is mounting evidence that pursuing a professional or graduate certificate may be a very savvy career investment. The popularity of certificates is on the rise. According to a 2012 study from the Georgetown University Center on Education and the Workforce, certificates are the fastest growing postsecondary credential, and second only to bachelor’s degrees in the number earned each year. About 10% of regulatory professionals now have postgraduate certifica...
  • Regulatory NewsRegulatory News

    FDA Launches New 'Trusted Trader' Import Program With Long List of Incentives

    The US Customs and Border Protection (CBP) and US Food and Drug Administration (FDA) have announced the launch of a new "Trusted Trader" program meant to expedite the import of products made by companies that meet a rigorous selection process. Background FDA and CBP have long sought to make improvements to the process used to import of products, and particularly pharmaceuticals. As explained in numerous Federal Register announcements over the years, the problem ...
  • Trade Associations Want Time Before Sunshine Act Begins

    • 29 August 2012
    The Centers for Medicare and Medicaid Services (CMS) is prepared to publish a final rule for the Physicians Payments Sunshine Act , but some trade associations are asking for more time before implementation of that rule. According to CMIO , four life science trade associations sent a letter to CMS, insisting sufficient notice be given before collection of data begins. They are asking for 180-day grace period after the final rule is released before reporting is required...
  • Supreme Court Upholds Majority of Affordable Care Act in Historic Decision

    • 28 June 2012
    In a historic decision, the Supreme Court has upheld the vast majority of the Patient Protection and Affordable Care Act (PPACA), ruling in a tightly-contest 5-4 decision that the law-and its individual mandate-could stand with some minor alterations. Chief Justice John Roberts, appointed by President George W. Bush, joined with Justices Ginsberg, Sotomayor, Kagan and Breyer to decide in favor of the law. One of the law's most contested provisions, the individual mand...
  • How Will the Supreme Court's Ruling Affect Pharmaceutical and Medical Device Companies?

    • 27 June 2012
    On 28 June 2012, the Supreme Court of the United States (SCOTUS) is expected to pass down several judgments deciding the fate of the Patient Protection and Affordable Care Act (PPACA)- a sprawling piece of legislation that has inspired deep division among the American public. At issue before the court is a series of court cases all asking SCOTUS a similar question: Is PPACA constitutional? As indicated by the questions asked by the justices during the cases' respecti...
  • Public Health Service Employees Not Subject to Whistleblower Protections

    The US Food and Drug Administration (FDA) counts among its ranks hundreds of Public Health Service (PHS) employees-members of a uniformed service charged with upholding and promoting public health and advancing public health science. While these employees are easily recognizable as a result of their military service uniforms, the federal government does not recognize a basic protection for these employees: whistleblowing protections. A Washington Post report details h...
  • New Insurance Product Covers Exposure to Health Fraud Cases

    • 05 March 2012
    Worried about your exposure to healthcare fraud? A new product is looking to protect employees at pharmaceutical, biotech and medical device companies-among others-that are worried about being the subject of health fraud investigation and subsequent action under the Park Doctrine, writes the Philadelphia Inquirer. The Park Doctrine holds that executives who fail to act in accordance with their responsibilities can be held personally responsible for fraud perpetrated ...