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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 Warns Korean OTC Drugmaker Using Noncompliant Contract Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Seoul, South Korea-based over-the-counter (OTC) drug manufacturer Seindni Co. for current good manufacturing practice (CGMP) violations and labeling concerns. The warning letter notes that the firm "lacks an adequate quality unit" and uses contract manufacturers for its OTC drugs distributed to the US, but during FDA’s inspection, Seindni "confirmed that your contract manufactur...
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    FDA Considers New User Fee Program for OTC Drugs

    The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs. User fee programs (such as PDUFA , GDUFA , BsUFA and MDUFA , all of which are now being re-negotiated for 2017) are the life blood of FDA and provide much-needed financial resources from industry, in addition to Congressional appropriations, that support the timely and efficient review of...
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    Asia Regulatory Roundup: China Looks to Revamp Drug Approval Process (3 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Proposes Drug Approval Reforms to Encourage Innovation Senior Chinese officials are considering adopting legislation that would overhaul the drug evaluation and approval process in the country to encourage innovation by incentivizing research. As it stands, only manufacturers can apply for drug approvals in China. Officials are now considering whether this disincen...
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    Asia Regulatory Roundup: India Looks to Join Pharma Inspection Scheme (15 September 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott Contests Indian Allegations of Substandard Cough Syrups A dispute between Abbott and regulators in India has raised doubts about the effectiveness of the quality testing regimens implemented by local authorities. The case centers on a sample of a product branded as Abbott’s cough syrup Phensedyl that was found to contain twice as much codeine as was listed on t...
  • TGA Proposes Warnings for OTC Oral Cough Medicines and Nasal Decongestants

    Australia's Therapeutic Goods Administration (TGA) has released for comment proposed new warnings on the label of some OTC cough medicines intended for oral use by children. The changes to the so-called Required Advisory Statements for Medicine Labels (RASML) follow recommendations made by TGA in 2012 to include warnings on products that contain the following ingredients: ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, phol...