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  • Regulatory NewsRegulatory News

    Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations

    As hormonal drugs to prevent pregnancy have evolved over the years, the US Food and Drug Administration (FDA) on Thursday drafted new guidance for drug developers on the recommendations for clinical trials designed to establish clinical effectiveness and safety for such products. In terms of key considerations for clinical trial design features, the six-page draft begins by explaining the recommended enrollment criteria for nonpregnant, premenopausal woman in trials, wh...
  • Regulatory NewsRegulatory News

    Updated: The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US

    Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years. In September, FDA granted tentative approval for Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog. On 11 December, Admelog received full approval from FDA. In the EU, howe...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Developing DAA Drugs to Treat Hepatitis C

    • 06 November 2017
    • By
    The US Food and Drug Administration (FDA) on Monday finalized draft guidance on developing direct-acting antiviral (DAA) drugs to treat Hepatitis C after revising the guidance twice. The guidance addresses nonclinical development, early clinical development and Phase 3 protocol designs, including trial design options, choice of noninferiority margins for active-controlled Phase 3 trials in the evaluation of interferon (IFN)- free regimens, and trial design options ...
  • Regulatory NewsRegulatory News

    CMS Shift on Biosimilar Reimbursement Under Part B: What to Expect

    The Centers for Medicare and Medicaid (CMS) last week announced a major shift in how it will reimburse for biosimilars under Medicare Part B, and though the agency and market might not see the full impact of the decision for another decade, experts explained to Focus what the change will likely mean in the near and long term. And though the predictions are largely hypothetical (since there are not currently multiple biosimilars for any reference biologic on the mar...
  • Regulatory NewsRegulatory News

    When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance

    The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted. The draft highlights criteria for submitting ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), petitioned ANDAs under section 505(j)(2)(C) ...
  • Regulatory NewsRegulatory News

    Malaysia Issues Compulsory License for Gilead Hepatitis C Drug

    Late last month, Malaysia's government issued a compulsory license in an effort to offer a less-expensive version of Gilead's hepatitis C drug and increase access. Reports of the government move in Malaysia coincided with Gilead's decision on 24 August to extend its voluntary licenses on its hepatitis C medicines to include Malaysia, Ukraine and Belarus. Previously, the company signed agreements with 11 India-based manufacturers to make generics of its hepati...
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    FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs

    The US Food and Drug Administration (FDA) on Wednesday warned patients and health care professionals not to use liquid drugs made by Florida-based contract manufacturing organization (CMO) PharmaTech LLC due to possible bacterial contamination. Last week, Rugby Laboratories issued a voluntary nationwide recall of all lots of two liquid docusate sodium laxatives, Diocto Liquid and Diocto Syrup, made by PharmaTech due to possible Burkholderia cepacia contamination. Wh...
  • Regulatory NewsRegulatory News

    FDA Considers Label Changes for Keytruda, Opdivo and Yervoy

    The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors. Currently, the labels of Bristol-Myers Squibb’s Yervoy (ipilimumab), Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) have uveitis listed as a potential immune-mediated adverse reaction (AR), and four of the five FDA-approved anti-PD1 therapies’ labels...
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    FDA Warns B. Braun Medical’s California Plant for Repeat Violations

    The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015. FDA found in its latest inspection from 18 April to 11 May 2016 that B. Braun’s "quality unit was not effectively exercising its responsibilities, particularly for investigating product defect complaints, manufacturing deviations, and adverse t...
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    WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

    A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement. "At the moment, there is no alternative levonorgestrel API which has been prequalified," WHO said Wednesday. When an API is prequalified by WHO, it can be used for the manufacture of finished pharmaceuti...
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    505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times

    With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development. Background Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosme...
  • Regulatory NewsRegulatory News

    CMS Drops Medicare Part B Drug Payment Pilot

    The Centers for Medicare and Medicaid Services (CMS) late Thursday decided to abandon a pilot plan that aimed to lower Medicare pharmaceutical spending. The Part B Drug Payment Model , first unveiled in March, would have tested whether alternative drug payment designs will lead to a reduction in Medicare expenditures. CMS said in a statement on Friday to Focus : "After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this Adm...