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    Switch in Adverse Event Reporting Forms Increased Quality and Quantity of Reports, FDA Study Finds

    Since 1969, health professionals and consumers have been able to voluntarily report pharmaceutical adverse events to FDA’s Adverse Event Reporting System (FAERS), and with a shift to plain language in the latest reporting form, a new study co-authored by FDA officials found that the quantity and quality of the adverse event reports has improved. The shift in mid-2013 to this plain language reporting form, known as the consumer voluntary reporting (ConVR) form or Form F...
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    As the Race for a Permanent FDA Commissioner Picks Up, Agency Turnover Continues

    With a decision on a permanent US Food and Drug Administration (FDA) Commissioner slated for the end of October at the latest, the steady stream of FDA employee defections to industry continues. So, who will be nominated as the next commissioner? Some influential health groups and former FDA commissioners (including Scott Gottlieb), according to the Washington Post , are pushing for Acting Commissioner Ned Sharpless to be nominated, while the Wall Street Journal...
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    FDA Offers Q&As on IS Response Variability in Chromatographic Analytical Data

    The US Food and Drug Administration’s (FDA) Office of Study Integrity and Surveillance, Office of Generic Drugs and Office of Clinical Pharmacology on Wednesday published a final question and answer (Q&A) guidance to help sponsors, applicants and contract research organizations with internal standard (IS) response variability in chromatographic analytical data. Such data can be submitted in investigational new drug applications, new drug applications, abbreviated new dr...
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    Health Canada’s Public Release of Drug, Device Clinical Data Picks Up Steam

    Last March, amendments to Canada’s  Food and Drug Regulations and the Medical Devices Regulations enabled the public release of clinical information submitted to Health Canada for new drug and device approvals. But in the first five months after the amendments took effect, just one clinical trial package for a new drug and one clinical trial package for a new device were published. In the last two months, however, Health Canada has published information on eight more d...
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    FDA Singles Out 9 More Drug Substances Not for Compounding

    Following a court win late last month to keep one such drug substance out of the hands of compounders, the US Food and Drug Administration (FDA) pointed to nine more bulk drug substances for which it has concluded that there is no clinical need for outsourcing facilities to compound them. For the nominated substances — dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue...
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    No-Deal Brexit: How Medicines and Devices Will be Regulated in the UK

    Although there may be another extension to Brexit day, the prospect for a no-deal Brexit at the end of October still looms large and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reiterated guidance on what will happen to drug and medical device regulations if such a no-deal path moves forward. On the side of minimal disruption, MHRA notes that transitional legislation will ensure that all currently granted Centrally Authorised Products ...
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    EMA Offers Edits on FDA Draft Guidance on Biosimilars

    Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late last month offered line-by-line comments and edits on a recently released draft guidance from the US Food and Drug Administration (FDA) on comparative analytical assessments for biosimilars. While noting the close collaboration between EMA and FDA on the statistical aspects of comparative analytical assessments, the EMA comments feature questions fo...
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    Help Wanted: CDRH Seeks Experts for 18 Advisory Panels

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday sought nominations for experts to serve as voting members of the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and panels that make up the Medical Devices Advisory Committee (MDAC). For DGMPAC, FDA is seeking experts in medical device quality management system requirements/current Good Manufacturing Practices, with experience in both 21 CFR part 820...
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    Rare Occurrence of Serious Liver Injury with 3 Hepatitis C Drugs, FDA Warns

    The US Food and Drug Administration (FDA) on Wednesday warned that it has received reports that the use of AbbVie’s Mavyret (glecaprevir/pibrentasvir), Merck’s Zepatier (elbasvir/grazoprevir) or Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. In 2018, an estimated 72,000 patients received prescriptions for the t...
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    FDA Clarifies Impurity Risks From ARB Recalls

    Following last summer’s discovery of nitrosamine impurities in angiotensin II receptor blocker (ARB) drugs, which led to numerous recalls of the blood pressure drugs, the US Food and Drug Administration (FDA) on Wednesday walked back its initial risk estimates. “We initially estimated  that if 8,000 people took the highest valsartan dose (320 mg) containing N-Nitrosodimethylamine (NDMA) from the recalled batches daily for four years, there may be one additional case of...
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    Academics and Researchers Raise Concerns With FDA’s Plan for ‘Integrated Reviews’

    More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the world are calling on the US Food and Drug Administration (FDA) to not replace its original reviews of medical products with an “integrated review” because of the valuable information that would be lost. The researchers claimed that such a shift would deprive them of information and data on the clinical studies and trials submitted to FDA, information on the postmar...
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    CDER Warns Chinese, Indian Manufacturers

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released two warning letters sent recently to India-based active pharmaceutical ingredient (API) manufacturer CTX Lifesciences Private Ltd and China-based drug manufacturer Ningbo Pulisi Daily Chemical Products Co. Following a six-day inspection at CTX Lifesciences, FDA found that the firm did not ensure that the water used for parenteral grade APIs was suitable for its...