echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > What is the trend for FDA approvals for new drug approvals to decline by 16% in 2019?

    What is the trend for FDA approvals for new drug approvals to decline by 16% in 2019?

    • Last Update: 2020-08-01
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    The U.S. Food and Drug Administration's (FDA) has seen a drop in new drug approvals by about 16 percent in 2019, according to a recent industry report released by GlobalData.
    according to the GlobalData's 10th edition of the Pharmaceutical Contract Manufacturing Organization (CMO) industry report "PharmSource-CMOScorecard: Outsourcing of NDA Approvals and CMO Performance - 2020 Edition" shows that the FDA approved 119 new drug listing applications (NDAs) and biologics license applications (BLAs) in 2019, including new molecular entities (NMEs) and new drug types.
    this number is 3 per cent higher than the average of 115 in 2014-2018, but down nearly 16 per cent from 137 approval records in 2018.
    report also noted that small-cap biopharmaceutical companies have higher outsourced production opportunities.
    Although the pharmaceutical industry's outsourcing tendency fluctuates from year to year, based on product volume analysis, the trend is relatively stable.
    Over the past decade, 79% of NMes and 67% of non-NME NDAs have been outsourced by small pharmaceutical companies.
    but CMO's overall performance fell last year.
    2019, only 44 OF the NDAs approved by the FDA came from contract manufacturers, below the 2014-2018 average of 55.6. Adam Bradbury, assistant medical analyst at
    GlobalData, said: "Most of the new drugs approved in 2019 are sponsored by large pharmaceutical companies, and the size of drug developers has historically been inversely proportional to the demand for contract manufacturing.
    , the total number of new drugs approved by the FDA in the U.S. has declined since 2018.
    the FDA suspended its review of existing trial new drugs (IND) and BLA applications due to the U.S. government's 'suspension' in January 2019, resulting in a reduction in the number of new items approved for the full year of 2019.
    these factors add up, resulting in a reduction in the number of outsourced products.
    " GlobalData, based on historical surveys, found that large-scale approvals would not be a trend, and that the number of non-disclosure agreements would continue to fluctuate from year to year.
    2018, the FDA's approval of new drugs broke the record since 1996, with 59 new drugs approved (including 42 NMEs and 17 BLAs).
    while the industry continues to look forward to this approval trend, only 48 new drugs will eventually be approved by the FDA in 2019, a decrease of about 18 percent.
    2010-2019 U.S. Drug Review Center (CDER) New Drug Approval Source: FDA Website 2020 New Drug Approval Trends: Decline or Growth The downward trend in approval of new drugs is an immediate thought of the impact of this year's global COVID-19 pandemic on the pharmaceutical industry.
    , evaluate Pharma, a pharmaceutical market research firm, released its latest data showing that the number of suspensions for Phase I-III clinical trials in clinical trials.gov, the U.S. clinical trial database, has increased 15-fold in the past two months, including 280 in March and 731 in April.
    source: Many experts on The XE: Evaluate Pharma's website has begun to speculate that COVID-19 will significantly affect the overall development of NDAs and those that are not used in new coronavirus treatments.
    but surprisingly, the number of new drugs approved by the FDA in the U.S. has reached 18 since January 2020, surpassing the record of 11 new drugs in January-May 2019, and even in the March-April of the COVID-19 outbreak in the U.S., the FDA approved eight new drugs (and more than a dozen emergency-use authorized products).
    U.S. FDA approval of new drugs as of May 14, 2020 Source: FDA website Undeniably, most of the new drugs approved so far in 2019 have completed clinical trials, data analysis and approval submissions, the application for listing has not been greatly affected, so the impact of COVID-19 on the market of new drugs may be from the second half of the FDA or 2021 approval records. "In this unprecedented era, it is difficult to predict how the COVID-19 crisis will affect drug approvals, pharmaceutical CMO and global supply chain networks, but the number of FDA approvals in 2020 is likely to be significantly affected, depending on the outcome of the outbreak's 'crisis'," said Bradbury,
    .
    " But for CMO, Bradbury noted that "the cMO industry is concerned that the number of product approvals from small and medium-sized pharmaceutical companies has started to decline significantly since 2018 and that the number of approvals from large pharmaceutical companies has risen sharply."
    ", "the CMO industry in the Us is likely to contract to some extent due to THE impact of COVID-19.
    "simple" change in new drug approval applications Although COVID-19 will seriously delay the introduction of new drugs, in recent years the drug approval process optimization, clinical trial data requirements simplified, is also accelerating the new drug market.
    a new study published in the April issue of JAMA magazine, a cross-sectional analysis of 273 FDA-approved drugs and biologics in the U.S. over the past 30 years found significant changes in the standards for new drug approvals in the U.S., with fewer critical trials based on drug approvals in recent years than in the past.
    The number of new drugs and biological products applying for this special regulatory program has been on the rise since the FDA adopted fast-track designations.
    for example, 29 (60%) had one or more special approval channels for 48 new drugs approved in 2019, of which 17 (35%) were awarded fast-track recognition, 13 (27%) were awarded breakthrough drugs, 28 (58%) were given priority approval and 9 (19%) were accelerated.
    source: "This change will have an impact on doctors and patients who are concerned about the 'quality' of new drugs, as well as drug regulators, as there is a growing need to continue to evaluate the safety and effectiveness of new drugs on the market."
    "But there is no doubt that, in the face of market and patient demand, new drug approvals are accelerating from the needs of the majority and will moderate the COVID-19 crisis."
    Reference: Novel Drug Approves for 2020 FDA new drug approvals down 16% in 2019 Report: NDA, BLA Approvalsby the FDA Fell 16% in2 019 Assess of The Clinical Trials Supporting USF ood and Drug Approval For The Agency of The Synderg for The DYNges.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.