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  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Promotional Drug Labeling and Ads

    The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs. FDA said it received one comment on the revised draft guidance, and in addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised dr...
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    Asia Regulatory Roundup: CFDA Posts Draft Guidance on Postapproval Manufacturing Changes (24 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Draft Guidance on Postapproval Manufacturing Changes China Food and Drug Administration (CFDA) is seeking feedback on its guidance on postapproval manufacturing revisions. The draft texts propose three tiers of changes to production processes and detail the regulatory steps companies need to take in each circumstance. Echoing draft guidance posted by the US...
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    European Regulatory Roundup: Commission Begins Investigation Into Cancer Drug Prices (18 May 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. European Commission Starts Formal Investigation into Aspen’s Cancer Drug Pricing The European Commission has opened a formal investigation into the way Aspen Pharma priced five cancer drugs. Officials began the probe after receiving reports indicating Aspen had imposed “very significant and unjustified price increases” on five off-patent cancer medicines it acquired ...
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Tells Manufacturers to Review Quality Systems to Ensure Data Integrity The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity. Offici...
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    PhRMA, Lilly and AbbVie Weigh FDA Plan to Study Twitter Drug Ads

    When the space of characters is limited, can a link to risk information be enough for drugmakers advertising their products on social media like Twitter? That’s the question the US Food and Drug Administration (FDA) asked last November and now industry is offering their opinions on the planned studies. As part of its planned study, FDA said on 7 November that it plans to conduct four studies, two involving Twitter and two using Google sponsored links, to determine how ...
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    FDA Warns Specialty Pharma Company Over Adverse Event Reporting

    The US Food and Drug Administration (FDA) sent a warning letter to Langhorne, Pennsylvania-based STI Pharma LLC for failing to meet the agency's requirements for adverse event reporting. FDA sent the warning letter following an inspection on 21 July 2016, during which FDA says it found the company lacked written procedures for gathering, evaluating and reporting postmarketing adverse drug experiences (PADE), which are required under federal regulations. "Given your reli...
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    Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Prepares Changes to Advertising Complaints Process The Therapeutic Goods Administration (TGA) of Australia is seeking industry feedback on the reform of the advertising complaints management process. TGA is considering either setting up a centralized process for handling complaints or outsourcing some or all of the work to an independent authority and wants to get...
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    Four Pharma Companies Lead in Regulatory, Legal Compliance

    Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...
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    FDA Kicks Pharma, Device Rule Finalizations Down the Road, Past Obama’s Presidency

    The US federal government is notoriously slow at promulgating new rules and bringing them into enforcement. But the US Food and Drug Administration (FDA) is taking that slowness to a whole new level for a host of potentially controversial final and proposed rules, some of which have lingered for decades. On Friday, the US Department of Health and Human Services (HHS), which FDA operates under, released its semiannual inventory of rulemaking actions under developm...
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    MHRA Delays Nordic Pharma’s Attempt to Add New Indian CMO Site to Marketing Authorization

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced that it has put on hold the addition of Indian contract manufacturing organization (CMO) Akums Drugs' Haridwar-based site as a manufacturing facility for the marketing authorization of Nordic Pharma's hormone injection progesterone due to a lack of sterility assurance. An MHRA inspection of the site (its first inspection for the site) on 13 April revealed one critical and three major...
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    FDA Warns CMO’s Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies

    Contract manufacturing organization (CMO) Corden Pharma’s Sermoneta, Italy-based site and Megafine’s active pharmaceutical ingredient (API) manufacturing site in Nashik, India, both received warning letters from the US Food and Drug Administration (FDA), which were released Tuesday. For the Italian site, which produces both APIs and finished drugs, FDA’s inspection from last May (warning letter was sent 24 May 2016) uncovered sterility concerns, including visible “black ...
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    Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

    Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...