• Regulatory NewsRegulatory News

    DIA: Experts offer advice on conducting decentralized trials

    There is an unprecedented level of support among regulators to advance the adoption of decentralized clinical trials, yet companies that undertake this mode of research need to be mindful of some of the challenges that can derail these efforts. Sponsors should keep their computer systems secure, closely adhere to patient privacy laws, as well as follow good clinical practices and adopt flexible uses of technology to ensure data can be collected remotely.   So assert...
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    House committee sends FDA budget to floor vote

    The US House Appropriations Committee has sent the Food and Drug Administration’s FY2023 funding bill to the full House for a vote. It includes an amendment to stop Russian drugmakers from selling their products in the US to protest the war in Ukraine.   On 23 June, the House Appropriations Committee voted 31 to 26, down party lines, to forward a $27.2 billion agriculture budget bill which includes $3.66 billion for FDA in FY2023. (RELATED: House subcommittee moves FD...
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    FDA explains when it will rescind breakthrough designations

    The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its evaluation of a drug.   While FDA has long asserted its authority to rescind or withdraw BTDs, the new guidance will add clarity for sponsors as to when the agency might revoke the designation. Since designation was created under the Food and Drug Administration Safety and Innovation Act in 2012,...
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    RWD in clinical trials: External control arms take the lead

    The US Food and Drug Administration (FDA) has now published four draft guidances spelling out how it will consider real-world data (RWD) in regulatory decision-making, from the use of electronic health records and registries to RWD in non-interventional studies. More guidance documents are planned, including details on study designs that incorporate RWD for external control arms.   External control arms, which use data collected outside of the current trial to provide ...
  • ReconRecon

    Recon: EMA recommends Valneva COVID vaccine; Novartis wins FDA approval for Tafinlar + Mekinist combo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen, citing insurance challenges, shutters one of its Aduhelm studies ( BioPharmaDive ) U.S. FDA labels Baxter's respiratory device recall as most serious ( Reuters ) Novartis wins U.S. approval for targeted cancer drug combination ( Reuters ) Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one ( STAT ) U.S. FD...
  • RoundupsRoundups

    Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver

    The World Trade Organization’s (WTO) agreement to a partial patent waiver for COVID-19 vaccines “sends a dangerous signal” to the pharmaceutical industry and all other innovative sectors, according to EFPIA, which expressed deep disappointment in the decision.   Twenty months after India and South Africa proposed an agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on COVID-19 vaccine patents, WTO has finalized the terms of a deal that will a...
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    FDA prevented record number of drug shortages in 2021

    The US Food and Drug Administration (FDA) prevented 317 drug shortages in 2021, the highest number since the agency began tracking drug shortages in 2012, according to a recent report released by the agency.   The agency’s Center for Drug Evaluation and Research (CDER) has been tracking drug shortages since the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed in 2012, which requires FDA to release an annual report to Congress; FDA’s Center f...
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    Draft guidance outlines FDA’s testing requirements for tissue containment systems

    A new draft guidance from the US Food and Drug Administration (FDA) lists potential non-clinical testing requirements for tissue containment systems used in power morcellation surgeries. The objective is to prevent potentially cancerous tissue from getting out of the containment systems and spreading the disease to other parts of the body.   On 17 June, FDA published a draft guidance titled Non-Clinical Performance Assessment of Tissue Containment Systems Used During...
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    DIA: Global initiative to standardize CMC quality data gaining steam

    CHICAGO – Several initiatives in the works among regulators and the pharmaceutical industry are gaining momentum to harmonize chemistry, manufacturing, and controls (CMC) information submitted in the Common Technical Document (CTD). One such effort is the formation of an industry consortium that is seeking to develop a structured content cloud-based CMC Module 3 template with input from regulators.   These plans were discussed on 20 June 2022 during the Drug Informatio...
  • ReconRecon

    Recon: Moderna touts bivalent booster’s response against Omicron subvariants; EU to raise investment in Latin American drug manufacturing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna booster candidate shows strong response against Omicron subvariants ( Reuters ) Moderna CEO: COVID variant vaccine to be ready for shipping in August ( Reuters ) Omicron-specific COVID vaccines on the horizon, Pfizer chief says ( Reuters ) More vulnerable people receiving fewer COVID pills - U.S. study ( Reuters ) FDA to Order Juul E-Cigarettes Off U....
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    EU reference labs: Commission adopts implementing acts

    A new set of implementing acts adopted by the European Commission outlines what EU reference laboratories need to consider in order to serve their customers. The regulations address issues such as how to ensure the labs have proper training and resources to handle workloads as well as how to ensure pricing transparency.   On 17 June, the Commission published two regulations on EU reference labs that may be used by notified bodies and member states to give technical ass...
  • ReconRecon

    Recon: Novartis loses patent appeal for MS drug Gilenya; European Commission investigates Vifor for anticompetitive practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 'Put up or shut up': Biden, Dems have one last chance to resurrect drug pricing reforms ahead of elections ( Endpoints ) Medicare could have saved billions on drugs if it paid what Mark Cuban charges at his new pharmacy ( STAT ) ( Endpoints ) Merck touts new data for breakthrough pneumococcal vaccine as it heads to PhIII trials ( Endpoints ) U.S. Supreme Court...