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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...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (9 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Ratchets up Pressure on Abbott, Medtronic to Keep Supplying Stents The National Pharmaceutical Pricing Authority (NPPA) of India has stepped up its attempts to stop Abbott Healthcare and Medtronic from curbing supply of their high-end cardiac stents. NPPA’s latest move is to encourage hospitals, doctors and patients to tell it if there is a shortage of certain br...
  • Regulatory NewsRegulatory News

    FDA Requires Label Changes to Better Protect Children From Pain and Cough Medicines

    The US Food and Drug Administration (FDA) on Thursday announced label changes to two opioids, codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks. Labels for both codeine and tramadol are being updated to include additional “Contraindications and Warnings.” Among the updates are contraindications for use of codeine or tramadol in all children younger...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Quality Control of Medical Devices China Food and Drug Administration (CFDA) has posted guidance on quality control and finished product release for medical devices. The document details the procurement control procedures, finished product inspection rules and other processes CFDA wants companies to establish to ensure medical devices meet manda...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (3 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Ends OTC Status of Codeine Drugs Following Review The Therapeutic Goods Administration (TGA) of Australia has reclassified codeine-containing drugs as prescription-only medicines. TGA decided to prohibit over-the-counter (OTC) sales of products containing codeine after reviewing the safety and efficacy of the painkiller and assessing how it is handled by foreign r...
  • Regulatory NewsRegulatory News

    TGA Weighs Rescheduling Codeine Following Safety Review

    Codeine-containing medicines may soon be available by prescription only in Australia, following a review and public consultation by the Therapeutic Goods Administration (TGA). Background In Australia, as in many other countries, medicines and other chemicals are classified in a schedule based on the level of regulatory control required for different substances according to their safety and use. Drug Schedules in Australia Schedule 1 Not currently in use Sched...
  • Regulatory NewsRegulatory News

    EU Committee Wants Additional Restrictions on Codeine Use in Children

    A European committee is recommending a series of restrictions on the use of medicines containing codeine in children. PRAC’s Recommendations Citing concerns that codeine can cause breathing problems and other serious adverse effects in children, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending codeine be contraindicated for children less than 12 years of age. Additionally, PRAC says that children between ages 12 ...
  • FDA Finalizes Boxed Warning for Codeine Product Associated with Pediatric Deaths

    US regulators have announced that prescription codeine will now be required to contain a boxed warning contraindicating its use in children who have just undergone a tonsillectomy procedure, saying that deaths and injuries have occurred after some children ultra-rapidly metabolized the drug into morphine. FDA's 20 February 2013 warning follows a preliminary one made in August 2012, in which it said that the drug has been associated with the deaths of at least three chi...
  • Australia: TGA Restricts OTC Cough and Cold Medications

    Australia's Therapeutic Goods Administration (TGA) has concluded that over-the-counter (OTC) cough and cold medicines registered with the agency should not be given to children under the age of six, and should be given only on the advice of health professionals for those ages six to 12. The restrictions stem from a review of the safety and efficacy of these products conducted by the agency that found although there are no immediate safety risks associated with the pro...
  • Genetic Predisposition to Codeine Overdose Potentially Fatal to Children, Warns FDA

    A popular painkiller may put children recovering from surgical procedures at greater risk for serious and potentially fatal side effects, the US Food and Drug Administration (FDA) said Wednesday, 15 August. The agency said it concerned about codeine -a painkiller commonly used after children have their tonsils or adenoids removed-and reports in scientific literature indicating at least three children may have died after taking the painkiller in a post-operative setting....