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  • Regulatory NewsRegulatory News

    FDA Bans Powdered Gloves

    The US Food and Drug Administration (FDA) on Friday issued a final rule banning powdered medical gloves beginning on 19 January 2017. FDA proposed the ban in March, citing mounting evidence that such gloves posed serious risks to patients, including airway and wound inflammation, post-surgical adhesions and allergic reactions. This is only the second time FDA has banned a medical device since banning prosthetic hair fibers in 1983. In April, FDA proposed banning a ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Reverses Opposition to Off-Label Ophthalmic Use of Avastin (15 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Reverses Opposition to Off-Label Ophthalmic Use of Avastin India has quickly reversed its opposition to the off-label ophthalmic use of Roche’s Avastin (bevacizumab).  Drug Controller General of India Dr. GN Singh warned against using Avastin in ophthalmology conditions in January after reports linking it to loss of vision emerged, only to withdraw the alert th...
  • Regulatory NewsRegulatory News

    FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood. FDA's guidance documents are its interpretations of regulations and legislation, which serve to "guide" persons or companies to a state of compliance. While t...
  • FDA: State, Federal Efforts to Reduce Access to Zohydro 'Extremely Troubling'

    Since the US Food and Drug Administration (FDA) approved Zogenix's non-abuse-deterrent pure hydrocodone painkiller Zohydro ER (hydrocodone bitartrate) in October 2013, groups opposed to the drug have proposed a number of ways to overrule the agency's approval order and remove the drug from the market. Legislators have called for FDA to reconsider. They've called for the government to investigate the approval. They've called for the Department of Health and Human Services...
  • Facing Shortages, Greece Bans Export of Drugs

    • 24 October 2012
    • By
    Greece is one of many countries, including the US and Canada, currently experiencing shortages of numerous drugs. But unlike other countries, Greece, which is in the midst of an economic crisis, has taken a novel and potentially controversial approach to solving the problem: it will no longer allow the export of pharmaceutical products from the country. Reuters reports the country's shortages are mainly the result of price slashing that the country has been forced ...
  • Massachusetts Loosens Ban on Industry Gifts

    • 10 July 2012
    • By
    The state of Massachusetts is loosening its controversial policy banning the pharmaceutical and medical device industries from giving physicians gifts, including compensated meals during continuing medical education. The measure has come under increasing fire in recent years as the economy has come to dominate matters of political discussion. Massachusetts' restaurant industry claimed the measure was hurting business as pharmaceutical companies no longer wined-and-dine...
  • Judge Calls FDA Decision on Antibiotics 'Arbitrary and Capricious,' Urges Reconsideration

    The US Food and Drug Administration (FDA) has suffered its second setback in as many months after Magistrate Judge Theodore Katz of the District Court of New York ordered the agency to reconsider two petitions which seek to ban the use of antibiotics in animals. FDA had rejected both petitions, respectively submitted to the agency in 1999 and 2005, citing "the time and expense required to evaluate individual drug safety and to hold formal withdrawal proceedings," reports...
  • FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire

    The US Food and Drug Administration (FDA) quietly moved to appeal a ruling by US Magistrate Judge Theodore Katz, who said the agency must either plan to withdraw its approval for most antibiotics used in animal feed or withdraw approval for their non-therapeutic applications. The agency, in conjunction with the US Department of Health and Human Services, filed an appeal with the US Second Circuit Court of Appeals in New York on 21 May. The case was originally filed by ...
  • Judge Orders FDA To Remove Antibiotics from Animal Feed

    A federal judge ruled this week that The US Food and Drug Administration (FDA) must either make plans to withdraw approval for the use of most antibiotics in animal feed or withdraw approval for non-therapeutic use of those antibiotics, reports Reuters . The 22 March ruling by US Magistrate Judge Theodore Katz comes after mounting concerns about antibiotic resistance and emerging so-called "superbugs" being seen as a threat to human health. Katz noted FDA had recently ...
  • Chinese Suppliers Tied to Tainted Heparin

    • 23 February 2012
    • By
    Fourteen Chinese companies have been linked to contaminated heparin, an anticoagulant commonly used during surgical procedures and dialysis, according to a Wall Street Journal report . The US Food and Drug Administration (FDA) added these companies to an import list allowing FDA to stop shipments at the border. That list already included eight other Chinese suppliers who were believe to have provided tainted raw materials for the making of heparin. The Wall Street J...
  • British Surgeons Group Calls for Ban on Cosmetic Surgery Advertising

    • 23 January 2012
    • By
    A British Surgeons group is calling for the cessation of cosmetic surgery advertising in light of what it sees as "marketing gimmicks" that lead to unsafe and unnecessary surgeries. The President of the British Association of Aesthetic Plastic Surgeons (BAAPS), Fazel Fatah told BBC news that "the many aggressive marketing gimmicks [not] only trivialize surgery but endanger the patient." Fatah further noted that patients are victim to "unrealistic expectations", "cras...