• Regulatory NewsRegulatory News

    CDER Warns Four Manufacturers From India, China and Canada

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released four warning letters sent to prescription drug, active pharmaceutical ingredient (API) and over-the-counter (OTC) drug manufacturers in China, India and Canada. Outlined below are the violations and FDA’s comments, with links to the warning letters in the sub-headings. Apotex Research Private Limited Just a day after receiving the first expedited generi...
  • ReconRecon

    Recon: Biogen’s Spinraza Too Costly for Britain; China Invalidates Patent on Gilead Hepatitis C Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US New York sues OxyContin maker Purdue Pharma over opioids ( Reuters ) Tech Giants Pledge to Ease Patient, Provider Access to Health Data ( WSJ ) ( The Hill ) Flagship Pioneering’s Sigilon gets a new CEO ( STAT- $) ( Endpoints ) ( Fierce ) Acorda Therapeutics CTO Leaves To Helm Unnamed Biotech Company ( BioSpace ) ( Fierce ) Carl Icahn Backs Off C...
  • Regulatory NewsRegulatory News

    Form 483s in India and China: Crunching the Numbers

    As China and India manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) has the enormous task of chasing down and regulating more than 1,000 manufacturing sites. Thanks to the Freedom of Information Act ,  Focus  obtained from FDA a list of all 483 Form 483s issued to China- and India- based manufacturers in 2017 – revealing many repeat offenders, many warning letters and many companies that ...
  • Regulatory NewsRegulatory News

    Advisory Committee Meeting to Focus on OPQ Priorities

    The Pharmaceutical Science and Clinical Pharmacology Advisory Committee will meet on 20 September to discuss two topics related to the Office of Pharmaceutical Quality’s (OPQ) priority of promoting better medicine. During the morning session of the meeting, the committee will discuss the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. “FDA will seek input on the potential enhancement of a...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Seeks Feedback on Use of Boxed Warnings to Highlight Safety Issues

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Use of Boxed Warnings to Highlight Safety Issues   The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on guidance about the boxed warnings used to highlight serious safety issues. TGA is running the consultation to understand whether people support the guidance and gauge how it will affect them.   Today, more than 30...
  • Regulatory NewsRegulatory News

    Gottlieb: FDA Approvals for Pediatric Devices Continue to Lag

    T he past decade has seen “far too few devices” on the US market designed specifically for diagnosing and treating pediatric populations despite recent legislative actions, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said during a public workshop Monday.   The pediatric device sector is fraught with challenges, noted participants at the first day of the two-day workshop, which forms part of a renewed push for pediatric medical device development....
  • Regulatory NewsRegulatory News

    AdvaMed Weighs FDA Draft Guidance on HDE Program

    Medical device industry group AdvaMed took issue with several parts of a recent draft guidance from the US Food and Drug Administration (FDA) on its humanitarian device exemption (HDE) program. In comments released Monday, AdvaMed said it disagreed with FDA’s position on what should be considered valid economic factors to determining profit eligibility, while also taking issue with a lack of clarity that randomized controlled trials are not necessary to demonstrate prob...
  • Regulatory NewsRegulatory News

    FDA to Study Drug Risk Information in DTC Print Ads

    The US Food and Drug Administration (FDA) said Monday it plans to conduct an experimental study on consumer impact from the amount and placement of risk information in prescription drug ads.   Sponsors tend to include risk information in both the “Important Safety Information” (ISI) section in direct-to-consumer (DTC) print ads and in a consumer brief summary, according to FDA.    “Including risks in both the ISI and the brief summary may have advantages,” FDA said...
  • Regulatory NewsRegulatory News

    Researchers Explain How FDA Should Implement Right to Try Law

    With the federal Right to Try Act now the law of the land, three academics are offering recommendations to FDA to try to help prevent the rise of unproven therapies and preserve the ability to collect critical information about investigational drugs, while enabling access. The three academics from the University of Pennsylvania, Georgia State University College of Law and Harvard Medical School explain in a JAMA viewpoint what the new law does and how it is similar to...
  • ReconRecon

    Recon: Regeneron’s Eylea Stumbles as FDA Issues CRL; Amicus Sets $315,000 Price for Fabry Disease Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Drug pricing watchdog group targets California Dem in $500K ad buy ( The Hill ) ( STAT ) Amicus sets $315,000 price for new Fabry disease treatment ( Reuters ) ( STAT ) ( Endpoints ) St. Jude and Mustang Bio enter into exclusive worldwide license agreement ( Memphis Business Journal -$) ( Endpoints ) ( Fierce ) MD Anderson, Accelerator bake up Mag...
  • Regulatory NewsRegulatory News

    FDA Approves First Contraceptive Mobile App

    A Swedish startup company obtained US Food and Drug Administration (FDA) approval Friday for the country’s first mobile medical app indicated for contraceptive use.   The Natural Cycles app features an algorithm that supports fertility awareness by gauging days of likely fertility based on menstrual cycles and daily body temperature data submitted by users.   To approve the app via the de novo pathway, the agency evaluated results from clinical studies that showed ...
  • Regulatory NewsRegulatory News

    Judge Denies J&J Motion to Dismiss Pfizer Lawsuit Over Remicade

    US District Court Judge Curtis Joyner on Friday denied Johnson & Johnson’s (J&J) attempt to scuttle a lawsuit brought by Pfizer over its failure to gain market penetration for its Remicade (infliximab) biosimilar Inflectra (infliximab-dyyb).   Pfizer alleges that J&J’s anticompetitive practices targeted both insurers and providers and involved exclusive contracts for Remicade, as well as myriad rebate games that prevented Pfizer and others from competing with Remicade....