• Regulatory NewsRegulatory News

    DSCSA: New interoperability ‘blueprint’ released

    With less than a year remaining before the Drug Supply Chain Security Act (DSCSA) takes full effect, an industry consortium has published new chapters of a guide to help drugmakers and their trading partners establish the necessary electronic systems to track their products through the supply chain.   The new chapters complement an earlier guide on understanding the compliance and baseline business requirements on trading of information, which was released in July 20...
  • Regulatory NewsRegulatory News

    EMA launches ‘stepwise PIP’ pilot

    The European Medicines Agency (EMA) on Monday launched a pilot program intended to allow greater flexibility for sponsors of innovative medicines in developing pediatric investigation plans (PIPs). Under the Stepwise PIP framework, EMA and sponsors may agree to a partial pediatric development program before agreeing to a full PIP later, as additional information about a drug becomes available.   The concept of a stepwise PIP stems from a 2018 multi-stakeholder workshop...
  • ReconRecon

    Recon: FDA links India-made eye drops to serious adverse events and one death; Gilead’s Trodelvy approved for a third US indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA says India-made eye drop linked to some infections, blindness and one death ( Reuters ) ( Bloomberg ) ( IndianExpress ) Gilead’s Trodelvy Approved for More US Cancer Patients ( Bloomberg ) ( Reuters ) ( Endpoints ) Biogen’s $1.5B Bet for Depressive Disorders Heads to FDA ( BioSpace ) ( Fierce ) ( Endpoints ) ( STAT ) Bountiful Approvals May Be Ahead As FDA...
  • Regulatory NewsRegulatory News

    EMA wants participants to serve on clinical trial multistakeholder forum

    The European Medicines Evaluation Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission are calling for representatives from the research community, pharmaceutical sponsors, academics and regulators to participate in a new multistakeholder platform (MSP) or forum to share and implement ideas for improving clinical trials in the EU.   The call for participation is being launched under last year’s EC-HMA-EMA initiative Accelerating Clinical Tri...
  • Regulatory NewsRegulatory News

    This Week at FDA: Restructuring at inspections office, new guidances and staff, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, the agency announced the launch of a new food program which includes restructuring its product inspections office. It also released a slew of guidances for devices and drugs.   After heavy criticism over the past year over its handling of the infant formula crisis, the US ...
  • Regulatory NewsRegulatory News

    FDA draft guidance addresses clinical development of drugs to treat early Lyme disease

    The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs to treat the early stages of Lyme disease.   The draft addresses criteria for clinical trial enrollment, efficacy endpoints, and clinical microbiology considerations for treating early stages of the disease when manifested by erythema migrans (EM), a rash that is often one of the first symptoms.   In North America, Lyme...
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    Shuren: FDA needs new authorities to prevent device shortages beyond public health emergencies

    The head of the US Food and Drug Administration’s (FDA) device center says he will continue to work with Congress and the medtech industry to pass legislation to prevent potential medical device shortages before a public health emergency must be declared.   Jeff Shuren, Center for Devices and Radiological Health (CDRH) director, spoke with Focus about his center’s performance last year and priorities for this year.   The FDA recently published the CDRH 2022 Annu...
  • ReconRecon

    Recon: US FDA gives thumbs up to GSK anemia drug; Vax makers kept $1.4 billion in COVID shot prepayments

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Glaxo’s Jesduvroq as Oral Treatment for Anemia ( Reuters ) ( Endpoints ) COVID-19 tracker: Merck pill linked to new mutations, study says ( Fierce ) ( Bloomberg ) FDA: Patients Can Get Paxlovid, Lagevrio Even With Negative COVID Test ( Inside Health Policy ) ( Endpoints ) What Changes When the COVID Emergency Ends in May? ( MedPage Today ) Modern...
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    FDA draft guidance addresses use of external controls to assess effectiveness of new drugs and biologics

    The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors can leverage external controls, such as use data from registries and electronic health records, in lieu of data from randomized controlled trials (RCTs) to demonstrate the safety and effectiveness of new drugs and biologics.   The draft guidance also describes how sponsors can communicate with FDA on using dat...
  • RoundupsRoundups

    Euro Roundup: EMA shares guidance on CTR, confidential data as new rules take effect

    The European Medicines Agency (EMA) has published a quick guide to the rules and procedures of the Clinical Trials Regulation (CTR) alongside questions and answers on protecting commercially confidential information when using the Clinical Trials Information System (CTIS).   Use of CTIS became mandatory on 31 January, turning the system into the single point of entry for the submission and assessment of clinical trial data.   The quick guide covers the basics of CT...
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    Medical device software regulations in the EU and US

    Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements. Medical device software is bound by regulatory requirements and constraints to ensure the medical devices will not harm patients. The EU and the US are significant markets for medical devices and the two largest global bodies responsible for issuing and managing medical devic...
  • Feature ArticlesFeature Articles

    Update on FDA regulation of ophthalmic combination products

    Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards has recently been affected by the legal requirement for the FDA to standardize the regulatory approach to ophthalmic products whose components are considered devices. The agency communicated the update through a guidance outlining the phase-i...