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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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    WHO to Craft Essential Diagnostics List

    The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL). The committee said the decision to begin developing such a list, agreed to earlier this month, may initially focus on in vitro diagnostics, with initial proposed priority areas including tuberculosis, malaria, HIV and hepatitis B and C. According to WHO , the list "should expand to other areas including other antimicrobial...
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    WHO Essential Medicines Update Adds Antibiotic use Framework and new HCV & HIV Drugs

    The World Health Organization (WHO) on Tuesday announced updates to its essential medicines list (EML), including new recommendations for antibiotic use and the addition of new drugs to treat hepatitis C, HIV and leukemia. The list, which is intended to serve as a model for the most crucial medicines for ensuring public health, is updated every other year based on recommendations from WHO's Expert Committee on the Selection and Use of Essential Medicines. "These medicin...
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    Top Ten Stories From 2016 by Traffic

    Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading! Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers : A perennial favorite, this explainer breaks down the latest in the lucrative world of PRVs. Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017 :...
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    FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

    The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list. If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first to be included on what’s known as the 503A bulks list. FDA’s Pharmacy Compoundi...
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    FDA Offers First Major Update to ‘Orange Book’ Website

    The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.” FDA's Orange Book is widely used in the regulatory community (and by doctors) for identifying which drug products are substitutable for one another, while FDA's Purple Book is list of all licensed biologics and biosimilars (the biological equivalent of the phar...
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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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    Updated Again: FDA to Pull Singapore Device Firm From Import Alert List

    A subsidiary of Biosensors International, a group of companies developing, manufacturing and marketing medical devices for cardiology and critical care procedures, failed to respond to an inspection request from the US Food and Drug Administration (FDA) and its products were banned from entering the US. However, five days after the company's name was posted on the import alert list, a Biosensors spokesman told  Focus  that the company will be removed from the list aft...
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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...