• Regulatory NewsRegulatory News

    FDA proposes breakthrough status for devices that address health disparities

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated breakthrough products. The agency is also considering expanding its criteria for breakthrough devices to include products that treat rare diseases, as well as non-addictive products to treat pain or addiction.   These updates were proposed in a recent draft guidance issued on Thursday. If ...
  • Regulatory NewsRegulatory News

    Pharma industry making some headway in DSCSA implementation

    The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA), according to a recent survey. Yet industry needs to pick up the pace if the November 2023 deadline is to be met, said an official with the Healthcare Distribution Alliance (HDA), whose group conducted the survey.   The survey found that 75% of manufacturers plan to send 100% of their DSCSA-req...
  • Regulatory NewsRegulatory News

    FDA finalizes guidances on device post-approval studies, postmarket surveillance

    The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the agency’s postmarket surveillance requirements and to better understand the agency’s expectations for conducting post-approval studies of these products.   The final versions contain minor changes from the draft versions released for comment in May 2021. (RELATED: FDA issues new draft guidances on devi...
  • Regulatory NewsRegulatory News

    FDA elevates OTAT to “Super Office” within CBER

    The US Food and Drug Administration (FDA) announced this week it has elevated and reorganized its Office of Tissues and Advanced Therapies (OTAT) to a “Super Office” within the Center of Biologics Research and Evaluation (CBER) to meet its growing workload and new commitments under the Prescription Drug User Fee Act (PDUFA VII) agreement for FY2023-2027.   The office will be renamed the Office of Therapeutic Products (OTP).   “With the current and anticipated incre...
  • Regulatory NewsRegulatory News

    FDA warns German OTC firm, Chinese API maker for lax cleaning practices, other GMP issues

    A German manufacturer of OTC products and a Chinese supplier of active pharmaceutical ingredients (APIs) were told to adopt better equipment cleaning practices in recent warning letters from the US Food and Drug Administration (FDA). The letters, posted on 27 September, also identified a slew of other current good manufacturing practice (CGMP) violations.   The first warning letter, to System Kosmetik Produktionsgesellschaft fur kosmetische, located in Munster, Germany...
  • Regulatory NewsRegulatory News

    Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

    Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how these assessments would work in practice, including how they would be coordinated with onsite inspections, whether they can be leveraged by foreign regulators and how FDA plans to ensure the privacy of companies and personnel tha...
  • Feature ArticlesFeature Articles

    FINALIST Maximizing the potential of the FDA assessment aid: Genentech’s experience

    The assessment aid (AAid), an initiative of the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE), was introduced in 2018 as a pilot program to help streamline the agency’s review of oncology drug applications. In this article, Genentech shares its experience with the AAid to date and provides recommendations for preparing the AAid and improving the process to fully realize its benefits. Keywords – assessment aid, FDA OCE pilots, oncology dr...
  • Regulatory NewsRegulatory News

    Groups weigh in on FDA’s licensing rules for 3PLs and distributors

    Supply chain trading partners expressed broad support for the US Food and Drug Administration’s (FDA) proposed rule on uniform licensing standards for wholesale distributors and third-party logistics providers (3PLs), which are set to replace the current patchwork system of state licensing standards. The standards implement aspects of the Drug Supply Chain Security Act (DSCSA) and are meant to plug holes in the country’s pharmaceutical supply chain.   The generic dru...
  • Regulatory NewsRegulatory News

    Pharma groups: FDA is exceeding its authority in risk management plan guidance

    The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of active pharmaceutical ingredients (APIs) as well as prescription drug manufacturers to submit risk management plans (RMPs) to avert drug shortages.   This requirement could impose the very drug shortages it is designed to prevent, instead of just targeting those products at risk of drug shortage, pharmace...
  • Regulatory NewsRegulatory News

    Warning letters: Investigators refused entry to testing lab; firm cited for distributing unauthorized COVID tests

    The US Food and Drug Administration (FDA) chastised a San Diego, California based testing lab in a recent warning letter for “significant deviations” from current good manufacturing practices (GMPs), including initially blocking investigators from entering the site, making false statements, failing to adequately the suitability of its analytical methods for testing products and lacking adequate safeguards over computer equipment.   In another recent warning letter, the...
  • Regulatory NewsRegulatory News

    OPQ’s FY2021 report gives mixed review on state of drug quality

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lists both negative and positive trends in its new report assessing the state of pharmaceutical quality in FY2021. Among the setbacks are the increasing number of drug recalls, under-reporting of quality issues in field alert reports (FARs) and a growing number of products failing sampling tests.   On the bright side, OPQ said its New Inspection Protocol Project (NIPP) program has increa...
  • Regulatory NewsRegulatory News

    Expert: OGD on track to approve more generic drugs in FY2022

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) will most likely approve a higher number of generic drugs in FY2022 compared to the prior year, and the number of generic applications received may continue to exceed OGD’s review capacity, asserted Robert Pollock, a senior advisor with Lachman Consultants.   Pollock, who regularly writes about FDA’s generic approvals, spoke to Regulatory Focus and shared these observations in his recent blog ...