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  • Regulatory NewsRegulatory News

    FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children

    The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18. “We are taking this action after conducting an extensive review and convening a  panel of outside experts . Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and dea...
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    FDA Finalizes Guidance on Antiviral Drugs for Cold Sores

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on developing antiviral drugs for recurrent herpes labialis (RHL), commonly referred to as cold sores, which affects between 20% and 40% of adults in the US. Specifically, the guidance details FDA's expectations for drugmakers to develop and test antiviral drugs to treat or prevent RHL from preclinical pharmacology and toxicology considerations to recommendations for designing Phase II and III clinic...
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    Asia Regulatory Roundup: India Caps Prices of Drug-Eluting and Bare-Metal Stents (26 July 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Caps Prices of Drug-Eluting and Bare-Metal Stents The Indian government has decided to cap the prices of drug-eluting and bare-metal stents. Officials reached the decision, which follows years of debate about the subject, after a subcommittee of cardiologists recommended that coronary stents be categorized as essential medical devices.  Members of the subcommittee ...
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    Transparency: What FDA Drug, Device Regulations are Coming Later in 2016

    As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules. By 31 March, according to the TRACK database, the agency expects to release four final rules and three propose...
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    Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions

    A group representing pharmacists in India is calling for regulators to amend the country's Drugs and Cosmetics Act to more strictly control how manufacturers specify temperature storage instructions for their products. Background The environment drugs and other healthcare products are stored in plays a critical role in ensuring their safety and efficacy. Manufacturers are required to control for a number of environmental factors, including temperature, humidity, ven...
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    FDA Facility Held Unknown Vials of Smallpox, Dengue, Q Fever and Other Deadly Diseases

    The US Food and Drug Administration (FDA), just days after announcing that it had found decades-old vials of variola —the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month. Dangerous Substances In a statement released to the press on 16 July 2014, the agency confirmed that it found hundreds—327 to be exact— of "carefully packaged v...
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    Medical Device Data Systems to be Exempt from Regulation, FDA Says

    In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices. The announcement comes more than three years after FDA down-classified MDDS devices from Class III ("high-risk") to Class I. Whil...
  • Rules for Blood Testing, Storage Changed

    • 29 August 2012
    The U.S. Food and Drug Administration (FDA) is changing the rules for human blood testing and storage, according to a report by in-Pharma Technologist . A new procedure issued by FDA allows for exceptions or alternatives with regard to blood, blood components or blood products. Requests for such exceptions or alternatives should be made in writing. Manufacturers can store thawed plasma at 1 to 6 degrees Celsius for up to 24 hours, according to the news report. Donors w...
  • European Commission Launches Prize Fund to Encourage Vaccine Temperature Stability

    The European Commission (EC) has launched a €2 million prize in the hopes that the incentive will drive inventors to develop vaccines that can be shipped and stored regardless of the temperature in which they are held. The prize, announced by EC's Commissioner for Research, Innovation and Science Máire Geoghegan-Quinn, should be of particular benefit to those patients in developing countries where cold-chain logistics networks are not established or unreliabl...