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    Do People Understand Cancer Drug Ads on TV? Drugmakers Weigh in on FDA Research

    As television ads for cancer drugs pose the question, “Who wouldn’t want a chance to live longer?” or present statements like: “Living longer is possible,” the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is trying to figure out if consumers can understand these drugs’ specific and often complicated indications supported by different types of endpoints. And now drugmakers Novartis, Merck and Eli Lilly are seeking modifications to ...
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    FDA Warns Chinese, Costa Rican Drugmakers

    The US Food and Drug Administration (FDA) last month warned Chinese active pharmaceutical ingredient (API) distributor Yino, Inc. and Costa Rican over-the-counter (OTC) drugmaker Polimeros y Servicios S.A. over good manufacturing practice (GMP) violations at their respective facilities.   Yino   In FDA’s warning letter to Yino, the agency takes the company to task after a five-day inspection of the company’s Chongqing facility in March identified issues with its ha...
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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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    FDA Proposes Adding Five New Substances to Pharmacy Compounding List

    The US Food and Drug Administration (FDA) on Wednesday proposed adding five new substances to the list of bulk drug substances that can be compounded by licensed pharmacists and physicians.   The agency also determined that another 26 bulk drug substances are not appropriate for compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA notes that it is still considering additional substances nominated for inclusion on the list that wi...
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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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    Stem Cells: FDA Warns Company for Selling Unapproved Products, Puts Others on Notice

    The US Food and Drug Administration (FDA) last week warned San Juan Capistrano, CA based stem cell clinic Stemell, Inc over its sale of unapproved umbilical cord products and for good tissue practice (GTP) and good manufacturing practice (GMP) violations following a week-long inspection in March.   “Those who are manufacturing or marketing unapproved, potentially unsafe products must understand that there’s a clear line between appropriate development of these products...
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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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    FDA Probe Into Patient Infections Over Contaminated Duodenoscopes Hits Turning Point

    Manufacturers of duodenoscopes in the US have come under new pressure to address the increased risk of patient infection, per the US Food and Drug Administration’s (FDA) request.   A Thursday safety communication notes how a probe dating back to FDA becoming aware of a potential association between multi-drug resistant bacteria and the use of duodenoscopes in 2013 is now getting to the heart of the matter, stemming from difficulties for hospital staff to follow reproce...
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    When FDA Can Accept Greater Premarket Uncertainty for Medical Devices

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized guidance on Thursday that explains when agency review staff may be able to accept greater premarket uncertainty about a device’s benefit-risk profile.   Revisions to the September 2018 draft version of the 22-page guidance document offer additional clarifications, reflecting recommendations industry offered during the public comment period. The guidance inform...