The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids

    A group of nearly two dozen Democratic legislators is calling on the US Food and Drug Administration (FDA) to label immediate-release opioids with more serious warnings meant to reflect "the serious risks of abuse" associated with the drug. In a letter sent on 4 June 2015 to FDA Acting Commissioner Stephen Ostroff, the legislators said their concerns are driven by "the national public health crisis of prescription drug overdoses." Opioid-related overdoses and deaths have...
  • Regulatory NewsRegulatory News

    Tougher FDA Approval Process for Opioids Sought by Congress

    New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). Background The bill, the FDA Accountability for Public Safety Act (FAPSA) , is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristi...
  • Regulatory NewsRegulatory News

    Legislators Call on FDA to Study use of Plastic Microbeads in Toothpastes

    Two US legislators are calling on the US Food and Drug Administration (FDA) to assess the "potential risks" associated with the use of polyethylene microbeads in consumer care products, including toothpastes, saying the products could pose a risk to public health. Background Microbeads have found their way into dozens of consumer products in recent years, most notably including cosmetics. The small plastic beads are used to give consumer products a textured feel, which ...
  • Regulatory NewsRegulatory News

    Legislators Call for FDA to Further Restrict Use of Phthalates in Medicines, Citing Risks

    In December 2012, the US Food and Drug Administration's (FDA) drug regulatory body, the Center for Drug Evaluation and Research (CDER), indicated that it wanted to limit the use of some phthalates as excipients in medicines. Now two legislators have a message for the agency: There's more that needs to be done. Background FDA's December 2012 guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products , explained that the agency had foun...
  • Regulatory NewsRegulatory News

    Legislators Ask FDA to Explain How it Missed Presence of Smallpox Vials for Decades

    The recent discovery of vials of smallpox and other potentially deadly pathogens at a facility controlled by the US Food and Drug Administration (FDA) raises "very serious questions" about federal regulators' capabilities and compliance with federal law, legislators said in a letter to FDA Commissioner Margaret Hamburg and other federal officials. Background FDA made headlines earlier this month when it announced that it had found vials of variola —the virus which caus...
  • Regulatory NewsRegulatory News

    ONC Director Defends Health IT Safety Center as it Struggles to Take Shape

    • 21 July 2014
    • By
    In response to pressure from members of Congress, a group of federal health IT regulators is clarifying which authorities a proposed Health IT Safety Center would—and would not —have. Background In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed into law, and with it a requirement that US Food and Drug Administration (FDA), the Office of the National Coordinator (ONC) for Health IT and the Federal Communication Commission all work...
  • Regulatory NewsRegulatory News

    House Republicans Increase Pressure on FDA Proposal, Citing Agency's 'Dubious' Behavior

    A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group. Background In November 2013, FDA unveiled a new proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products . The rule wou...
  • Regulatory NewsRegulatory News

    Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

    • 10 July 2014
    • By
    Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US. Background The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States , is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under the ...
  • Regulatory NewsRegulatory News

    Legislators Want More Transparency About How Drugs Impact Women

    More than a month after pressing the US Food and Drug Administration (FDA) to do more to promote the participation of women and minorities in clinical trials, more than a dozen members of Congress are again pressing government officials to take action on the issue, this time focusing their efforts on clinical data transparency. Background In March 2014, a bipartisan group of female senators wrote to FDA , urging it to do more to ensure the equitable participation...
  • Regulatory NewsRegulatory News

    FDA, Absent From Hearing, Makes the Case That it's Increasingly Innovative

    Yesterday, US legislators in the House Energy and Commerce Committee held a hearing to discuss how the federal environment—including the US Food and Drug Administration's (FDA) regulations—might be improved to bolster drug innovation. But while the pharmaceutical industry, device industry and patient groups found themselves well represented at the meeting, one prominent stakeholder found itself conspicuously excluded from the meeting: The US Food and Drug Administration. ...
  • Regulatory NewsRegulatory News

    Legislators Borrow From FDA's Approach in Seeking Patient Input About Regulatory Process

    House legislators are quickly moving ahead with a new plan that hopes to overhaul how the US regulatory system reviews new medical products, and are now soliciting input from a group that has not traditionally been at the center of the regulatory process: patient advocacy groups. Background In late April 2014, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) announced the launch of a new initiative called the " 21st Century Cures Initiative ," which they said would be a...
  • Senators Press FDA to Explain Regulation of Generic Opioids

    A group of senators are pressing the US Food and Drug Administration (FDA) to provide a more predictable pathway to market for generic opioid painkillers in the hopes of ensuring that new versions of the drug will retain the abuse-deterrent qualities of the existing products. Background FDA's policies on generic opioid painkillers have always been a bit wonky on account of the agency needing to balance two competing factors: policy and law. On one hand, the agency want...