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    Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds

    The rare pediatric priority review voucher (PRV) program was not found to be associated with an increase in the number or rate of new rare pediatric disease drugs that began clinical trials, a Health Affairs study found. But the researchers from Harvard Medical School, working on what they said is the first study on the impact of the rare disease PRV program on drug development, also found that their data do provide some encouraging news about rare pediatric disease d...
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    ICH Seeks to Harmonize Generic Drug Standards

    With an aim to harmonize the technical and scientific standards for generic drugs across borders, the International Council on Harmonization (ICH) on Wednesday released a reflection paper outlining an approach to begin supporting such efforts. The reflection paper offers recommendations to develop a series of ICH guidelines on standards for demonstrating bioequivalence for non-complex and more complex dosage forms and products. It also describes the remit of the Informa...
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    PhRMA, AAM Seek Tweaks to FDA’s Verification Guidance

    Pharmaceutical and generic drug industry groups are seeking changes to US Food and Drug Administration (FDA) draft guidance on the verification systems that can determine, quarantine and investigate suspect or illegitimate products. The 11-page draft, released last October, lays out how FDA recommends that trading partners submit cleared product notifications (ie. that a product is not illegitimate) and the statutory requirements for verification, including verificati...
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    Combo Product Reviews: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how sponsors can determine which type of premarket submission is appropriate. The 22-page draft, which implements a section of the 21 st Century Cures Act , explains what combination products are, how their various FDA center assignments are determined and considerations for making approval pathway de...
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    FDA Warns Company for Failing to Complete Postmarket Requirement

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Lymol Medical Corporation for failing to comply with the milestone date in the completion of a postmarketing requirement (PMR) for its sterile talc powder. FDA said the company did not demonstrate a good cause for its failure to complete the study, which was supposed to be a risk assessment study on the lead content of sterile talc powder in line with ICH’s Q3D Elemental Impurities gu...
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    Sanofi Raises Public Health Questions on Use of Nonsense Suffixes With New Vaccines

    A lot of ink has been spilled on the controversial random suffixes that the US Food and Drug Administration (FDA) is now tagging on the end of the nonproprietary names of biologics and biosimilars. Back in January 2017, FDA finalized a guidance document spelling out how this four-letter, FDA-designated meaningless suffix would be attached at the end of biologics’ and biosimilars’ nonproprietary names. Later in 2017 and 2018, companies began to realize FDA was only u...
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    USP’s Generics Access Plan to Aid FDA Efforts

    USP last week unveiled a new Generic Access Plan as part of its collaboration with the US Food and Drug Administration (FDA) to better facilitate generic drug competition.   As part of the plan, USP has pledged to develop and update quality standards supporting FDA’s Drug Competition Action Plan (DCAP), which includes a list of off-patent drugs for which there are no generic alternatives. “Manufacturers can rely on USP quality standards, helping accelerate availabil...
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    EMA Updates Brexit Guidance

    The European Medicines Agency (EMA) and other EU bodies have updated technical and practical guidance, as well as a document describing the legal obligations for drug manufacturers under Brexit. The three documents include an updated Q&A and a 23-page practical guidance – both addressing a situation where the UK leaves the EU without a withdrawal agreement – and a document on legal rules that explains how EU rules in the field of medicinal products for human and veterin...
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    Shakeup at the Top of FDA’s Biosimilars Division

    The US Food and Drug Administration (FDA) on Friday announced that Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs (OND), has decided to leave FDA and will depart 22 February. Christl is moving to Amgen. Amgen told Focus Christl will be joining as executive director, global regulatory and R&D policy on 11 March. After joining FDA in 2003, Christl since 2010 has been at the forefront of biosimilar policy an...
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    China’s NMPA Cites Overseas Device, IVD Companies

    China’s National Medical Products Administration (NMPA) published overseas inspection results in late January, highlighting 17 overseas medical device and IVD manufacturers that were cited, including BD and Boston Scientific.   Since November 2017, when NMPA began to publish overseas inspection results, a total of 41 manufacturers have been cited, according to ChinaMed Device, LLC, which is a medical device and IVD consulting firm based in Boston, and is a certified NM...
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    EU Begins Transition to Electronic Product Information for Medicines

    The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) on Thursday launched a six-month public consultation on the draft key principles that will form the basis for creating electronic product information (ePI) for medicines in the EU. Derived from conversations with EMA, EC, HMA and various stakeholders, the draft key principles explain how ePI, which includes the package leaflet for patients and the summary of product...
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    Mylan Wins FDA Approval for First Advair Generic

    The US Food and Drug Administration (FDA) late Wednesday approved the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Generating almost $80 billion in sales since its initial launch, competi...