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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Provides Guidance as Black Triangle Adverse Event Scheme Goes Live Australia’s Therapeutic Goods Administration (TGA) has posted guidance on its black triangle adverse event reporting scheme. The scheme came into force at the start of the year, leading TGA to share a guide that addresses some of the uncertainties expressed by industry in advance of the go-live day...
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    Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Tightens Stem Cell Guidelines to Curb ‘Rampant’ Unethical Therapeutic Practices India has tightened its guidelines on the banking and therapeutic use of stem cells in response to “rampant unethical practices.” The updated guidelines strengthen mechanisms for the review and monitoring of stem cell clinical trials and prohibit commercial banking of most biological ...
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    Researchers Call for Transparency When Black Box Warnings Are Removed

    A team of Harvard researchers are calling for the US Food and Drug Administration (FDA) to develop guidelines detailing its decision-making process for removing black box warnings from drug labels. In a recent article appearing in Drug Safety , James Yeh, Ameet Sarpatwari and Aaron Kesselheim of Bringham and Women's Hospital and Harvard Medical School argue that by making the process to remove such warnings from drugs "uniform and transparent," FDA could increase public...
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    FDA: New Postmarketing Study, Black Box Warning for Essure

    This article has been updated with more information presented by FDA in a press call Monday and the release of the draft guidance referenced in FDA's announcement. After months of deliberation, the US Food and Drug Administration (FDA) announced on Monday that it will require a new postmarketing study and a black box warning label for Bayer's permanent birth control device Essure. Essure is marketed as a non-surgical alternative to tubal ligation and consists of a pai...
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    State Health Officials Petition FDA for New Warnings on Opioids, Benzodiazepines

    Concerns over the risks of co-prescribing benzodiazepine and opioid drugs has 41 state health officials petitioning the US Food and Drug Administration (FDA) to place a new black box warning on both classes of pharmaceuticals to warn patients and doctors of the potential risks with concomitant use. “Only a few labels and medication guides contain specific information on the dangers of concurrent use of these two classes of medications; none contain black box warnings,” t...
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    Researchers Link FDA Actions to Decrease in LABA Use in Asthma Treatment

    A recent study finds an association between regulatory actions by the US Food and Drug Administration (FDA) and the use of long-acting β2-agonists (LABA) commonly used to treat asthma. The study, published in the Journal of Allergy and Clinical Immunology in December, was conducted by a team of researchers at Kaiser Permanente, Harvard Medical School, Vanderbilt University and several FDA offices. In the study, the authors observed a slight, but statistically signific...
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    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...
  • Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed

    Less than a month after US regulators issued a preliminary warning about the cardiovascular risks associated with products intended to treat low testosterone levels in men, a prominent consumer advocacy group is calling on the US Food and Drug Administration (FDA) to add more serious warnings to the products. Background FDA's review of the products, commonly known as "low-T" drugs, was triggered by two separate studies. The studies, in the  Journal of the American...
  • Analysis: OPDP More Likely to Issue Warning Letters if Drug has Black Box Warning

    Assume for a moment that you're a manufacturer of a pharmaceutical product, one with recognized benefits but enough potential risks to warrant a Boxed Warning on your product's label. Now here's a question for you: Is your product more likely or less likely to eventually receive a Warning Letter from the US Food and Drug Administration (FDA) if you commit an advertising violation relative to a regularly-labeled product? If you answered in the affirmative-that is, mo...
  • 43 Attorneys General: New Black Box Warning Needed to Prevent Neonatal Death

    The National Association of Attorneys General, an organization comprised of all state attorneys general, has sent a letter to US Food and Drug Administration (FDA) Commissioner Margaret Hamburg asking her to add a black box warning to all narcotic analgesics in the hopes of reducing risks to newborn children. The Letter At issue for the 43 signatories of the letter is the potential for opioid abuse by pregnant women to lead to Neonatal Abstinence Syndrome (NAS), a syn...
  • China Finalizes Guidance Approving Counterfeit Manufacturer 'Black Lists'

    China's State Food and Drug Administration (SFDA) issued new regulations on 15 August instructing provincial governments to publish on their websites so-called Black Lists of drug and device companies that engage in counterfeiting and related illegal activities.   The websites are to include the name of the company, its business address, the name of the legal representative or responsible person, and the individual's title.  Violations that would justify...
  • Study: FDA's Risk Communications and Warnings Not as Effective as Hoped

    A new meta-analysis in the journal Medical Care looking at the effect of risk communications sent out by the US Food and Drug Administration (FDA) finds an inconsistent response to FDA's attempts to warn the public about the potential harms associated with some medications. The study looked at 49 studies published between 1990 and 2010 which evaluated the impact of FDA risk communications, including safety alerts, letters to healthcare providers and black box warnings....