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  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    Bespoke therapies – opportunities, challenges, and hope

    This article discusses the advent of bespoke therapies, defined as the tailoring of medical treatment to the individual characteristics or symptoms and responses of a patient during all stages of care and as a new frontier beyond personalized medicine. The author covers the revolutionary genetic tools implementing such therapies and the clinical and nonclinical safety perspectives for bespoke therapies. The author concludes that with bespoke therapies we are entering a new...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    The article discusses drug shortages in Germany the root causes of production problems with active pharmaceutical ingredients and drug product manufacturers. The authors offer analysis from a medium-sized generic drug manufacturer’s perspective. They offer a variety of reasons, all of which point to a “broken marketplace.” The article concludes with a discussion of mitigation activities and in an epilog address the current COVID-19 pandemic, warning that drugs and active i...
  • Regulatory NewsRegulatory News

    Pelosi Drug Pricing Bill Advances on Party-Line Votes

    Two House committees on Thursday advanced on party-line votes Speaker Nancy Pelosi’s (D-CA) bill to allow for the negotiation of certain medicine prices as part of plans to bring down costs in the US. No major amendments were adopted in either the Energy & Commerce or the Education & Labor committees’ meetings, although the amendments in the E&C meeting ranged from carving out specific disease treatments from negotiations to requiring the Health and Human Services Sec...
  • Regulatory NewsRegulatory News

    Another Record Year for Generic Drug Approvals but Questions on Competition Remain

    For each of the last five years, the US Food and Drug Administration (FDA) has set generic drug approval records, but questions have lingered on whether these high approval numbers are translating into competition. FY 2019 figures show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals), which breaks FDA’s previous all-time record of 971 full and tentative approvals for FY 2018 . And although the abbreviated new drug application (...
  • Regulatory NewsRegulatory News

    CBO: Pelosi Bill Will Save Hundreds of Billions, Reduce Number of New Drugs to Market

    The Congressional Budget Office (CBO) late Friday announced that House Speaker Nancy Pelosi’s (D-CA) drug pricing bill would reduce federal direct spending for Medicare by $345 billion from 2023 to 2029, but it would also lead to a reduction of approximately 8 to 15 new drugs coming to market over the next 10 years. The CBO report comes as rhetoric on both sides of the aisle has picked up in recent weeks, with industry group PhRMA referring to the bill, known as HR 3, a...
  • Regulatory NewsRegulatory News

    Is FDA Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss

    From industry to academia, commenters have argued that the US Food and Drug Administration’s (FDA) drug approval standards are becoming inappropriately low and that the required postapproval evaluations are either inadequate or left undone. But three senior FDA officials offered several counterpoints on Monday at the fifth annual Biopharma Congress in Washington, DC. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained that the agency ...
  • Regulatory NewsRegulatory News

    Nevada Fines Drugmakers $17M for Failing to Comply With Drug Pricing Law

    The Nevada Department of Health and Human Services this week sent letters to 21 diabetes drug manufacturers seeking $17.4 million in penalties for non-compliance with a new price transparency law. “This legislation requires the Department to compile a report of information related to prescription drugs used to treat diabetes. As part of the legislation, the Department of Health and Human Services (DHHS) can impose a penalty for companies who fail to provide the required...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese Drug Testing Facility for Refusing Inspection

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in August to China-based drug testing facility Shanghai Institute of Pharmaceutical Industry for refusing an inspection. FDA had planned a surveillance and pre-approval inspection of the facility from 29 November to 4 December 2018, but the company told FDA’s China office in a written response that it was refusing the inspection. "Under section 501(j) of the Federal Food, Drug, and Co...
  • Regulatory NewsRegulatory News

    Pelosi Unveils Plan to Lower Prescription Drug Prices

    As Sen. Chuck Grassley (R-IA) continues to push his own competing drug pricing legislation in the Senate, House Speaker Nancy Pelosi (D-CA) unveiled her proposal to lower prescription drug prices on Thursday, with a plan likely to please more liberal Democrats and further distance Republicans. At the heart of Pelosi’s plan is the idea to allow Health and Human Services Secretary Alex Azar to select between 25 and 250 drugs annually and directly negotiate with manufactur...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA to Congress: Pediatric Information Lacking in 36% of Relevant Orphan Drug Labels

    In a report to Congress, the US Food and Drug Administration said that there is a public health need for additional pediatric information in labeling for over one-third of approved orphan indications that are relevant in the pediatric population. FDA research, conducted as part of the FDA Reauthorization Act of 2017  (FDARA), found that of all drugs that were approved for an orphan indication between 1 April 1999 and 31 August 2018, a total of 548 orphan indications we...