• Regulatory NewsRegulatory News

    Experts Discuss CDRH Proposals That May Require New Authorities

    From a pre-certification (PreCert) approach on software as a medical device (SaMD) and laboratory-developed tests (LDTs) to cybersecurity and the 510(k) premarket review pathway, the US Food and Drug Administration (FDA) has set forth several proposals that may require additional statutory authority. Legal experts at the AdvaMed Digital MedTech Conference in San Francisco this week shed light on the specific areas within FDA’s existing statutory authority that pose ques...
  • Regulatory NewsRegulatory News

    FDA Issues Drug Compounding Small Entity Compliance Guide

    The US Food and Drug Administration (FDA) on Thursday issued a new questions and answers guidance intended to explain how small entities can comply with its recent final rule detailing the bulk drug substances that can be used in compounded drugs.   In February, FDA finalized its list of bulk drug substances that can be used to compound drugs under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The list currently includes six bulk drug substan...
  • Regulatory NewsRegulatory News

    Industry Seeks More From FDA on Natural History Study Guidance

    Merck, Lundbeck and Ionis Pharmaceuticals are seeking more details from the US Food and Drug Administration’s (FDA) draft guidance on natural history studies, including discussions of using third-party disease registries. The 19-page draft guidance, released in March , describes the potential uses of a natural history study in all phases of rare disease drug development. It covers the strengths and weaknesses of various types of natural history study designs, common da...
  • ReconRecon

    Recon: FDA Approves Novartis’ SMA Gene Therapy With $2.1M Price Tag

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US $2.1 million drug to treat rare genetic disease approved by FDA ( NBC ) ( STAT ) ( FDA ) JPMorgan cuts ties with OxyContin maker Purdue Pharma ( Reuters ) ( CBS ) ( NBC ) McKinsey No Longer Consulting for Purdue, Ends Opioid Work ( Bloomberg ) Trump Administration Preparing Executive Order on Health-Cost Disclosure ( WSJ ) Senate bill to cut health costs, tar...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 24 May 2019 to include: FDA approved Novartis' Zolgensma to treat childr...
  • Feature ArticlesFeature Articles

    Will the FDA Precertification Pilot Program Work?

    This article discusses the new pilot program from FDA that aims to make it easier for qualified companies to move software through premarket review, while better leveraging postmarket data collection, and whether the program will work in practice as planned.   Introduction   Digital health products often fall into a class of their own. With the tsunami of Software as a Medical Device (SaMD) products soon to go through the approval process, FDA is proactively lookin...
  • Regulatory NewsRegulatory News

    When a Retweet is Considered Promotional, MHRA Takes Action

    Companies’ promotional use of social media can run afoul of regulators, even if it’s just the promotion of another account’s post, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) reaffirmed Friday. MHRA took issue with OTC pharmaceutical manufacturer Thornton & Ross for retweets of third-party content referring to the company’s cough syrup Covonia. MHRA said the retweets “constituted promotional material and therefore should include the statutory inf...
  • Regulatory NewsRegulatory News

    Experts Examine Impact of EU GDPR, CCPA on MedTech Sector

    An expert panel at the AdvaMed Digital MedTech Conference in San Francisco on Wednesday discussed the impact on the medical technology sector from new legislation that enacted changes to privacy rights and data protection. Last year saw some major changes to regulation in US and EU law on data privacy and protection. To enhance privacy rights and data protection, the EU’s General Data Protection Regulation (GDPR) was implemented last May and the California Consumer Priv...
  • Regulatory NewsRegulatory News

    FDA Clears New Tests for Chlamydia, Gonorrhea, Zika Virus and Prosthetic Joint Infections

    The US Food and Drug Administration (FDA) on Thursday cleared three new tests that can detect the presence of chlamydia and gonorrhea and authorized the marketing of a diagnostic to detect Zika virus immunoglobulin (IgM) antibodies in human blood.   The agency also authorized the first diagnostic to aid in detecting whether a patient has an injection around a prosthetic joint implant.   Hologic’s Aptima Combo 2 Assay and Cepheid’s Xpert CT/NG are the first devices ...
  • Regulatory NewsRegulatory News

    Senate Bill to Cut Health Costs, Targets FDA Tweaks

    The Senate Health, Education, Labor and Pensions (HELP) committee on Thursday unveiled a discussion draft of a new wide-ranging bill to help cut health care costs. The draft includes nine sections related to the US Food and Drug Administration (FDA), including efforts mirroring House-passed bills reforming the Orange Book and Purple Book, as well as initiatives to increase generic drug competition. Former FDA Commissioner Scott Gottlieb praised the Senate draft : ...
  • Regulatory NewsRegulatory News

    FTC Finds Dwindling Number of Anticompetitive Reverse Payment Deals

    The Federal Trade Commission (FTC) on Thursday released a report on Hatch-Waxman patent settlements in FY 2016, finding an increase in the total number of settlements, but a major decrease in anticompetitive reverse payment settlements. In fact, FTC found that only one of the 232 agreements between generic and brand drug companies in 2016 contained a side deal or no authorized generic commitment. This was the lowest number of such pay-for-delay agreements since 2004. ...
  • ReconRecon

    Recon: Gottlieb Returns to Biotech VC Firm; UN Creates New Ebola Chief Role

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Former FDA head Scott Gottlieb rejoins VC firm ( Axios ) ( WSJ ) ( Endpoints ) ( Fierce ) Novartis CEO plans gene therapy price 'far lower' than $4 million to $5 million range ( Reuters ) ( STAT ) Did FDA unfairly treat Catalyst by approving a similar drug from another company? ( STAT ) In a change of plans, Nektar spins out its opioid into a new biotech subsi...