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  • Regulatory NewsRegulatory News

    FDA Warns 5 Drugmakers in China, Australia and Austria

    The five warning letters sent from the US Food and Drug Administration (FDA) in December and January and released this week deal with violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients (APIs). Shanwei Honghui Daily Appliance  Following an FDA inspection of the Shanwei, China-based facility in July and August, agency inspectors noted “filling machines used to manufacture over the cou...
  • Regulatory NewsRegulatory News

    FDA Warns Four Foreign Drug Manufacturers

    The US Food and Drug Administration (FDA) on Tuesday released four warning letters sent in September to drug manufacturers from China, the UK, the Netherlands and Switzerland. The warning letters are part of a wider crackdown by FDA on foreign drug manufacturers, particularly in China and India . Data manipulation has been a primary concern for FDA, in addition to trying to deal with manufacturers that refuse inspections . China For the warning letter sent 26 Se...
  • Regulatory NewsRegulatory News

    CFDA’s Domestic Pharma Manufacturing Site Inspections Decline Significantly

    China’s Food and Drug Administration (CFDA) in 2015 inspected less than half the number of pharmaceutical manufacturers as compared with 2014, according to a recently released annual report from the Center for Food and Drug Inspection of CFDA. The report claims that as the number of domestic inspections has decreased significantly, “the proportion of enterprises going through rectification inspection and receiving Warning Letters has significantly increased, with the rat...
  • Regulatory NewsRegulatory News

    FDA Warns Taiwanese Drug Manufacturer Over Significant cGMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter for Taiwanese drug and contract manufacturer Ko Da Pharmaceutical over four specific violations. The letter from FDA’s Center for Drug Evaluation and Research, sent 27 May, revealed the following significant violations of current good manufacturing practice (cGMP):  Ko Da’s quality control unit failed to approve or reject all procedures or specifications impacting the identity, strength...
  • Regulatory NewsRegulatory News

    OPDP Untitled Letter Takes Issue With Shionogi's Copay Assistance Voucher

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has found that Shionogi’s “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion to help treat head lice is false or misleading because it omits important risk information. The omission of such risk information means that the voucher misbrands Ulesfia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative, ...
  • Regulatory NewsRegulatory News

    FDA Warns Indian Drugmaker Over Major Data Integrity Violations at Three Plants

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to India-based Ipca Laboratories after inspections at three of its manufacturing facilities revealed data integrity violations. All three of the plants are already banned from sending products to the US. The warning letter, dated 29 January, reveals how inspectors found “systemic data manipulation” at Ipca’s Ratlam facility in Madhya Pradesh, “including actions taken by multiple analysts, on...
  • China's SFDA Issues Rule on Imposing Administrative Penalties

    China's State Food and Drug Administration (SFDA) issued a  notice  to the Provinces and Autonomous Regions regarding the application of its Administrative Punishment law, which sets forth the rules for imposing sanctions for violations of the laws and regulations governing drugs and devices.  Local authorities are allowed leeway in deciding the severity of the penalty that is to be imposed on a case-by-case basis, taking into consideration the nature of ...
  • Proposed Bill Exempts Minor First-Time Regulatory Violations from Civil Fines

    • 02 August 2012
    • By
    A new bill proposed in the US House of Representatives would provide relief to small companies and other entities found to be violating paperwork-based regulations for the first time. The bill, the Providing Assistance with the Paperwork from Excessive Regulations Act of 2012 , was introduced 26 July 2012 by Rep. Austin Scott (R-GA) . Under the act, first-time offenders would not be assessed a civil fine if they commit a "paperwork violation." Though the legislat...
  • Feature ArticlesFeature Articles

    Pitfalls in Good Clinical Practice

    A pitfall can be defined as a potential and usually unanticipated disaster or difficulty. 1 When we perform clinical studies we try to anticipate unforeseen pitfalls before they arise. However, other occurrences are clearly foreseeable, yet we permit them-or cause them-to happen. Good Clinical Practice (GCP) refers to international standards of quality for the performance of clinical studies with human subjects. These standards aim to ensure the data generated are h...
  • Reeling from Regulatory Hit, Ranbaxy Takes Q4 Loss

    Indian drug manufacturer Ranbaxy Laboratories, still reeling from a $500 million fine paid for regulatory violations, announced on 24 February that it would suffer a $607 million loss despite increased sales.  Ranbaxy had announced on 26 January that it would settle with the US Department of Justice after US regulators found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and the US. The settlement required them to pa...
  • Big Pharma Faces Prospect of Big Fines in 2012

    • 23 January 2012
    • By
    Some of the world's largest pharmaceutical companies are facing "costly settlements" during 2012 thanks to aggressive investigations and enforcement by US agencies and a wide-ranging list of improper activities allegedly perpetrated by the pharmaceutical companies, according to an analysis by The Financial Times . US agencies are currently separately investigating Pfizer, GlaxoSmithKline, Merck, Baxter, Bristol Myers Squibb, Eli Lilly, AstraZeneca and Smith & Neph...