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  • Regulatory NewsRegulatory News

    Pfizer Not Planning US Launch of its Second Remicade Biosimilar Approved by FDA

    The US Food and Drug Administration (FDA) late Wednesday approved the ninth biosimilar in the US and the third for J&J’s Remicade (infliximab). But Pfizer said it will not launch Ixifi (infliximab-qbtx) in the US as the company already has another Remicade biosimilar on the market, known as Inflectra (infliximab-dyyb) (the third Remicade biosimilar is Merck and Samsung Bioepis’  Renflexis  (infliximab-abda)). Pfizer spokesman Thomas Biegi explained to Focu s that Ix...
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    Asia Regulatory Roundup: India Orders J&J and Others to Maintain Output of Knee Implants (3 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Orders J&J, Other Device Makers to Maintain Output of Knee Implants The Indian government has ordered Johnson & Johnson and a clutch of other device makers to maintain output of knee implants at pre-August levels. Officials invoked the legislation to stop the companies from cutting production in response to the price ceiling the government brought into force in ...
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    Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars

    Pfizer on Wednesday filed a complaint in a US District Court in Pennsylvania alleging that Johnson & Johnson (J&J) is using "improper exclusionary tactics" to maintain dominance in the US market for its blockbuster Remicade (infliximab) despite recently introduced competition. First approved in 1998, J&J's tumor necrosis factor-inhibiting biologic is used to treat a range of immune-mediated diseases in almost 500,000 Americans, including for Crohn's disease, ulcerat...
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    Asia Regulatory Roundup: CFDA Expands Trial Data Quality Monitoring Drive to Cover Medical Devices (11 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Boehringer, J&J Pressure TGA to Bring ‘Out of Date’ Advertising Framework into Digital era Boehringer Ingelheim and Johnson & Johnson have called for the Australian regulator to bring its advertising framework into the digital era. The Therapeutic Goods Administration (TGA) stands accused of operating an out-of-date framework that has failed to adapt to the rise of ad...
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    Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council

    Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements. J&J calls on FDA’s new council to address the process and principles for determining the primary mode of action with cross-center collaboration to ensure technical considerations are included in the dec...
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    Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. J&J, Novartis and Pfizer Comment on TGA Risk Management Proposals Johnson & Johnson, Novartis and Pfizer say they are broadly in favor of the Therapeutic Goods Administration’s (TGA) proposed framework for risk-management plans, but have some specific suggestions as to how it can be improved. TGA released version 3.0 of its guidance on risk management plans for medic...
  • Regulatory NewsRegulatory News

    Dr. Khoo Teng Chuan, Co-Chair of the RAPS Pan Asia Advisory Committee, Dies at 56

    Dr. Khoo Teng Chuan, a leader and expert in the pharmaceutical and medical device sectors across Asia, passed away on Tuesday at the age of 56. Most recently, Dr. Khoo worked as chief medical officer for the Singapore Clinical Research Institute, after joining the institute as senior vice president in 2010. In this role as chief medical officer, he worked closely with Singapore’s national agencies including the National Medical Research Council, Health Sciences Aut...
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    J&J’s Regulatory Executives Groomed as Business Leaders

    Over the past decade, life sciences companies have increasingly realized that regulatory expertise is a mission-critical business asset. The amount of time regulatory professionals spend on business and management-related duties has risen sharply at all job levels, according to RAPS’ own Scope of Practice & Compensation Study . Some, more forward-thinking companies are taking this a step further, actively grooming regulatory professionals to be business leaders and crea...
  • J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • J&J to Pay $2.2 Billion for Off-Label Marketing of Risperdal in Third-Largest Settlement Ever

    The US Department of Justice (DOJ) has announced that Johnson & Johnson will pay at least $2.2 billion to resolve claims that it improperly marketed three drugs for indications not approved by the US Food and Drug Administration (FDA). The amount, which includes fines, forfeitures and settlement fees, amounts to one of the largest healthcare-related civil settlements in US history. Background The settlement between J&J and DOJ has long been in the works. In Jun...
  • FDA Announces Bevy of Sterility-Related Recalls

    The US Food and Drug Administration's (FDA) MedWatch staff had an unusually busy 6-8 September 2013 weekend, announcing the recall of products from three companies due to serious problems that could potentially affect patient safety. The Return of Recalls for McNeil One of the three companies is McNeil Consumer Healthcare, a Johnson & Johnson subsidiary that has conducted a number of high-profile recalls of many widely available products in recent years, including...
  • J&J's Janssen Gets Second Untitled Letter in as Many Months as FDA Targets Xarelto Advertising Piece

    On Wednesday, the US Food and Drug Administration (FDA) released the text of a new Untitled Letter sent to Johnson & Johnson - the second sent in as many months to the same company - regarding promotional material for its blockbuster anticoagulant Xarelto (rivaroxaban), alleging that the company failed to present the risks of the drug in a fair and balanced manner. Background: Doxil Untitled Letters are less serious than the more widely-known Warning Letters, whic...