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  • Regulatory NewsRegulatory News

    FDA lists medical devices in shortage under CARES authority

    For the first time, the US Food and Drug Administration (FDA) on Friday listed medical devices in shortage or that have been discontinued during the coronavirus disease (COVID-19) public health emergency using a new authority under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   The CARES Act amended the Federal Food, Drug, and Cosmetic Act by adding Section 506J, which requires manufacturers of certain devices to notify the agency of manufa...
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    Sterilization Facility Closure Leads to First Device Shortage

    With the closure of a medical device sterilization facility in Illinois, the US Food and Drug Administration (FDA) warned of device shortages, and last Friday announced a type of a tracheostomy tube manufactured by Smiths Medical is the first to be in shortage. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement : “I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization chal...
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    Generic Drug Prices ‘Strongly Predictive’ of Shortages, Study Finds

    How a generic drug is priced may be the difference between whether it experiences a shortage or not, a new study published in Value in Health found. The study of commonly used outpatient generic drugs from 2008 to 2014 found that the prevalence of shortages decreased from a peak in 2011-2012 to less than 4% of the overall sample by the end of 2014. Generic drug prices “were strongly predictive of drug shortages,” the researchers found. But competition and market si...
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    FDA Spotlights Recent Spike in Drug Shortages

    The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages, according to agency presentations at an FDA/Duke Margolis Center for Health Policy event on Tuesday. Matthew Rosenberg, an economics staffer at FDA, looked at drug shortages in terms of occurrence, duration, intensity and public health impact. Combining data from FDA archives and IQVIA national sales database, Rosenbe...
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    Mandatory Reporting of Drug Shortages to Begin in Australia in 2019

    Beginning 1 January 2019, drugmakers will be required to report drug shortages in Australia, the country's Therapeutic Goods Administration (TGA) announced Tuesday. “Medicine shortages have become an increasing problem in Australia, as the current voluntary scheme for reporting shortages has proven ineffective,” TGA said, noting that many critical shortages are not currently reported, meaning such information cannot be shared with consumers and health professionals, whi...
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    Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Asks China to Expedite GMP Inspections, Resolving Essential Medicine Shortage India has resolved the shortage of a rare disease drug after asking China to expedite the inspection of a manufacturer of active pharmaceutical ingredients (APIs). The Drug Controller General of India (DCGI) made the cross-border intervention to accelerate the resumption of API supply ...
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    FDA Staff Shortages May Get Worse With Trump’s Federal Hiring Freeze

    On Monday, President Donald Trump signed an executive order to freeze all federal government hiring and with the US Food and Drug Administration (FDA) lacking almost 1,000 employees, the freeze could further slow new drug, medical device and generic drug approvals. What’s unclear right now is whether the order, which stipulates that the “head of any executive department or agency may exempt from the hiring freeze any positions that it deems necessary to meet national s...
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    Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval

    Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC). Benjamin Davies, MD, an associate professor of urology at the University of Pittsburgh School Of Medicine, writing in Forbes on Thursday, called on the government t...
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    European Regulatory Roundup: Ireland to Offer Regulatory Advice via New Innovation Office (17 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Ireland Creates Innovation Office to Provide Regulatory Advice The Health Products Regulatory Authority (HPRA) of Ireland has created an Innovation Office to give advice to developers of novel health products and technologies. HPRA sees the office facilitating the timely development of innovative interventions by providing regulatory input early in the process. Staff ...
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    Medical Device Manufacturer Pleads Guilty to Misbranding and Agrees to Pay $36M

    Pennsylvania-based medical device manufacturer Biocompatibles Inc., a BTG subsidiary, pleaded guilty earlier this week to misbranding its embolic device used to treat liver cancer, among other diseases, and will pay more than $36 million due its illegal conduct, the Justice Department (DOJ) said.  Under the terms of the plea agreement before the US District Court for the District of Columbia, Biocompatibles pleaded guilty to a misdemeanor charge in connection with the ...
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    Asia Regulatory Roundup: CFDA Looks to Resolve Vaccine Shortages (12 July 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Calls on Regional Regulators to Work to Resolve Vaccine Shortages The China Food and Drug Administration (CFDA) has called on its regional offices to take steps to resolve the country’s vaccine supply shortage. The request comes at a time when CFDA and the vaccine industry it regulates are adapting to the changes that were proposed in response to the scandal that rece...
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    Updated: EMA Warns of Possible Chemotherapy Shortage in Four Countries Due to Sanofi Manufacturing Snafu

    Fifteen batches of Sanofi’s chemotherapy Taxotere (docetaxel) have been recalled due to a problem in the manufacturing process that could have led to vials being too concentrated, the European Medicines Agency (EMA) said in an updated alert on the possible shortage on Thursday. A failure in the filling process at Sanofi’s manufacturing site in Germany has led to Taxotere vials being up to 5% over-concentrated, EMA said. The drug is used to treat breast cancer, non-s...