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  • Regulatory NewsRegulatory News

    PDUFA VII: FDA and industry set priorities in first round of negotiations

    After kicking off the Prescription Drug User Fee Act (PDUFA) reauthorization process in July, the US Food and Drug Administration (FDA) has released the first set of meeting summaries in its ongoing negotiations with industry that will shape its prescription drug review program from FY2023-2027.   The meeting summaries, while brief, provide insights into what FDA and industry hope to get out of the multi-billion-dollar agreement, with representatives from government ...
  • Regulatory NewsRegulatory News

    Lack of product-specific guidance slows ANDAs: FDA study

    Researchers at the US Food and Drug Administration (FDA) found that, for drugs that are new chemical entities, generic submissions were more likely when the reference brand-name drug generated more revenue.   Looking into other factors that predict that an abbreviated new drug application (ANDA) will be filed for a reference drug, the investigators also found that sponsors were less likely to file ANDAs for complex drugs.   In a retrospective study examining 400 br...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. The Herculean effort means that a fast-tracked vaccine could come to market anywhere from the  end of 2020  to the middle of  2021 .   To date, just two coronavirus vaccine has been  approved . Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamaleya Research Institute in Moscow – was approved by the Ministry of Health of th...
  • Regulatory NewsRegulatory News

    Euro Convergence: EMA makes case for multi-stakeholder response to emerging challenges

    The idea that regulatory agencies can come up with solutions in isolation is “very dangerous” and underscores the need for multi-stakeholder responses to emerging challenges, said Anthony Humphreys, of the European Medicines Agency (EMA), at the Euro Convergence 2020 virtual meeting.   Speaking during a session on supporting innovation, Humphreys, head of EMA’s regulatory science and innovation taskforce, set out the importance of gathering the views of other stakehold...
  • RoundupsRoundups

    Euro Roundup: MHRA shares post-Brexit assessment routes, variations guidances

    New guidances from the Medicines and Healthcare products Regulatory Agency (MHRA) address new assessment routes, marketing variation processes and rules on converting Community Marketing Authorisations (CAPs) that will apply to products sold in the United Kingdom post-Brexit.   The new assessment routes include an accelerated assessment pathway that, like its EMA equivalent, will reduce the regulatory review timeline to 150 days, according to the guidance.   The pa...
  • ReconRecon

    Recon: Novartis buys Vedere Bio for $150M upfront; Gilead reports $873M in remdesivir sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A P value of 0.38? NEJM results raise new questions for Eli Lilly's vaunted Covid antibody ( Endpoints ) ( NEJM ) Regeneron Covid-19 Therapy Reduces Viral Load, Need for Care ( Bloomberg ) ( Endpoints ) ( NBC ) Antibody drugs seem to work. But the virus is moving faster than we can make them ( STAT ) Moderna on track to report late-stage COVID-19 vaccine data ...
  • Euro Convergence: Navigating changing regulation of drug-device combination products

    As European regulators prepare to implement new requirements for drug-device combination products under the upcoming Medical Device Regulation (MDR), manufacturers and notified bodies are grappling with some of the lingering questions. “There are still some gaps… and some areas where we’d like to see more certainty, but until then we will continue to keep the dialogue going,” Jonathan Sutch, PhD, senior medicinal specialist at the notified body BSI Group, said during a ...
  • Regulatory NewsRegulatory News

    Euro Convergence: Pragmatic approaches to data collection needed to meet MDR

    Manufacturers have a narrowing window of opportunity during which to find pragmatic ways for gathering post-market data to support continued use of products under the Medical Device Regulation (MDR), according to experts who spoke at the Euro Convergence 2020 virtual meeting.   The outgoing Medical Device Directive (MDD) contains scant information on post-market surveillance (PMS) and post-market clinical follow-up (PMCF). MDD contains two uses of the term PMS, creatin...
  • Regulatory NewsRegulatory News

    EMA rolls out implementation plan to address nitrosamine impurities

    The European Medicines Agency (EMA) has rolled out its full plan to implement recommendations to reduce the risk that medicines will be contaminated with nitrosamine impurities, identifying short-, medium- and long-range priorities. The agency has also made templates available for marketing authorization holders to perform risk assessment and confirmatory testing.   The implementation plan builds out a framework for putting in place the specific recommendations of a ...
  • RoundupsRoundups

    FDA Approvals Roundup: Remdesivir, Eysuvis, Sklice

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Remdesivir gets the go-ahead for COVID-19 Gilead Sciences’ Veklury (remdesivir) has been approved for the treatment of older children and adults who are hospitalized with COVID-19. [SEE: Remdesivir receives FDA approval for COVID-19 , Regulatory Focus , 22 October 2020]   New indications Eysuvis okayed for short-term treatment of dry e...
  • ReconRecon

    Recon: Sanofi, GSK to supply 200M vaccine doses to COVAX scheme; US strikes deal for Lilly’s COVID antibody drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer CEO All but Rules Out Vaccine Before Election Day ( NYTimes ) ( FT ) US strikes deal with Lilly for potential COVID-19 antibody drug ( Reuters ) ( Endpoints ) ( Press ) Lawmakers release trove of Purdue documents detailing Sackler family’s involvement in opioid sales ( STAT ) I'm the FDA point person on COVID-19 vaccines. We'll make sure they're safe an...
  • Regulatory NewsRegulatory News

    MDUFA V: Industry wants fine tuning while FDA seeks expansion

    The US Food and Drug Administration (FDA) kicked off the negotiation process that will inform the fifth iteration of the Medical Device User Fee Amendments (MDUFA V) program via a virtual public meeting on Tuesday.   The meeting, initially scheduled to take place in April, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s medical device program from FY2023-FY2027.   During the meeting, FDA officials...