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    FDA Warns McKesson for Distributing Illegitimate Products

    In its first warning letter issued under the Drug Supply Chain Security Act (DSCSA) ,  the US Food and Drug Administration (FDA) on Tuesday detailed how San Francisco-based McKesson distributed illegitimate drugs to pharmacies. In September and October 2016, McKesson was notified that three separate Rite Aid pharmacies in Michigan received illegitimate product, which had been distributed by McKesson. “The seal of the bottle was broken, and the bottle contained no o...
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    EU Looks to Craft Harmonized Definition of a Drug Shortage

    Part of what’s holding back a more concerted European-wide push to combat and manage drug shortages is a harmonized definition for a shortage, according to a report released Monday on a November meeting discussing the availability of authorized medicines. “The lack of a European-wide definition for shortages has long been a factor hampering a harmonised European-wide approach to managing shortages,” the report says. Annette Byrholt Hansen from the Danish medicines Ag...
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    CERSI Collaborations With FDA: Priority Research

    Since 2012, the US Food and Drug Administration (FDA) has engaged with universities across the country on dedicated research projects targeting the agency’s public health priorities. Frank Weichold of FDA’s Office of the Chief Scientist recently explained in Clinical Pharmacology & Therapeutics how the work at the four Centers for Regulatory Science and Innovation (CERSI) supported by cooperative agreement grants from FDA is going. The four CERSIs currently are the Un...
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    Poland, Slovenia Added to GMP Agreement Between US and EU

    Earlier this month, the US Food and Drug Administration (FDA) confirmed the capabilities of Poland and Slovenia to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. FDA can now rely on a total of 22 member states to replace their own inspections, although the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all EU member states' authorities for human pharmaceuticals. ...
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    FDA Targets Products Falsely Claiming to Treat Alzheimer’s Disease

    Developing treatments for Alzheimer’s disease has been notoriously difficult, and now the US Food and Drug Administration (FDA) is cracking down on companies fraudulently claiming that their dietary supplements can help treat, prevent or even cure the disease. FDA on Monday released 12 warning letters and five advisory letters to foreign and domestic companies that are illegally selling more than 58 unapproved new drugs and/or misbranded drugs that claim to prevent, tre...
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    Failing to Disclose Foreign Influence: NIH Seeks OIG Help

    Sen. Chuck Grassley’s (R-IA) inquiry into whether National Institutes of Health (NIH) medical research might be influenced by foreign entities led to revelations this week that the inspector general for the Department of Health and Human Services (OIG) is investigating a dozen allegations of noncompliance. The inspector general noted that these referrals primarily dealt with the failure of principal researchers to disclose foreign affiliations.  “These new referrals ...
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    Exemptions for Unclassified Devices: CDRH Updates Guidance

    The US Food and Drug Administration (FDA) on Friday updated a guidance from 2015 describing its intent to exempt certain unclassified medical devices from premarket notification requirements. “Until the publication of a final rule exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period,” the guidance says. Un...
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    FDA Raises Concerns With 505(q) Petitions

    In a report to Congress, the US Food and Drug Administration (FDA) took issue with a certain statute that requires FDA to prioritize petitions seeking to delay product approvals above other safety petitions that raise public health concerns. “FDA continues to be concerned that section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the agency sa...
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    FDA Seeks to Establish DSCSA Pilot Projects

    As part of efforts to reduce the diversion of drugs in the US and to help deter counterfeit drugs from entering the supply chain, the US Food and Drug Administration (FDA) is seeking participants for pilot projects related to the requirements of the Drug Supply Chain Security Act (DSCSA). The pilot projects are intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of an interoperable electronic system to be established b...
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    Final Deadline for Falsified Medicines Directive Set for Saturday

    EU member states have until 9 February to implement the final part of the Falsified Medicines Directive (FMD), though the British Medical Association says that only 15% of products are expected to be compliant. The prospect of a hard Brexit is also raising questions about whether the UK will have access to the EU repository of centralized data, which would create difficulties for UK stakeholders in verifying the unique identifier (UI) on each medicine’s package. The ...
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    Shared REMS: FDA Explains Policies and Procedures

    The US Food and Drug Administration (FDA) on Thursday posted a manual of policies and procedures (MAPP) explaining the policies, responsibilities and procedures by FDA for developing a single, shared system (SSS) risk evaluation and mitigation strategy (REMS). More specifically, the MAPP deals with an SSS REMS with elements to assure safe use (ETASU) for a reference listed drug (RLD) and abbreviated new drug application (ANDA) that references the RLD during the review o...
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    Australia Looks to Improve Generic Drug Authorization Process

    Australia’s Therapeutic Goods Administration (TGA) announced Thursday that it’s considering a range of options to improve the generic medicine registration process. Chief among those options is TGA’s consideration to allow the use of overseas reference product in bioequivalence studies, as currently the reference product used in such studies must be an existing medicine approved in Australia. “Our requirements are largely consistent with comparable overseas regulator...