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  • Feature ArticlesFeature Articles

    FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective

    Despite all of the public discussion about FDA's enforcement approach in the off-label promotional arena, the agency continues to take action against any perceived unlawful promotion. Recently, FDA issued Notice of Violation letters to drug companies for promoting their investigational new drugs as safe and effective. Introduction The US Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) did not take the summer off, despite the uncertainty sur...
  • Regulatory NewsRegulatory News

    MHRA Delays Nordic Pharma’s Attempt to Add New Indian CMO Site to Marketing Authorization

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Friday announced that it has put on hold the addition of Indian contract manufacturing organization (CMO) Akums Drugs' Haridwar-based site as a manufacturing facility for the marketing authorization of Nordic Pharma's hormone injection progesterone due to a lack of sterility assurance. An MHRA inspection of the site (its first inspection for the site) on 13 April revealed one critical and three major...
  • Regulatory NewsRegulatory News

    EMA Reviewing Indian CRO Semler After FDA Warns of Data Integrity Issues

    The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility. EMA says it is conducting its review based on the issues raised by recent notices from the US Food and Drug Administration (FDA) and World Health Organization (WHO). According to EMA, th...
  • Regulatory NewsRegulatory News

    WHO Declares Public Health Emergency Over Microcephaly, Zika Suspected as Cause

    The World Health Organization (WHO) on Monday declared a public health emergency in response to clusters of microcephaly and Guillain-Barré Syndrome (GBS) in Brazil and French Polynesia suspected to be caused by the Zika virus. "I am now declaring that the recent clusters of microcephaly and other neurological abnormalities reported in Latin America, following a similar cluster reported in French Polynesia in 2014 constitutes a Public Health Emergency of International Co...
  • Regulatory NewsRegulatory News

    WHO Raises Serious Concerns With Indian TB Drugmaker

    World Health Organization (WHO) inspectors earlier this week released a letter uncovering a number of safety issues at a Mumbai-based manufacturer of tuberculosis drugs. WHO said its inspection at the facility of Svizera Labs, which is part of Maneesh Pharmaceuticals, from June 2015 uncovered several critical and major deviations from WHO Good Manufacturing Practice standards and this latest Notice of Concern letter includes deficiencies that are still a problem for the ...
  • Regulatory NewsRegulatory News

    After Court Rulings, Canada Proposes Changes to Combination Drug Requirements

    Canada is looking to amend its Patented Medicines (Notice of Compliance) Regulations after two high-profile court rulings took a strict interpretation of the regulations that would make it more difficult to protect combination drugs under the regulations. Background In Canada, a notice of compliance is issued to a drug company when its product has been authorized. The requirements for a notice of compliance to be issued can be found in C.08.004 of the Food and D...
  • Untitled Letter to Acorda Therapeutics Highlights Recent FDA Review Trends

    The US Food and Drug Administration (FDA) sent two untitled warning letters to pharmaceutical companies in as many days in June, warning two companies regarding alleged infractions contained within marketing videos. The first of the letters cited Valeant Pharmaceuticals -which owns the New Drug Application for Xenazine, actively marketed by Lundbeck-for purportedly omitting risk information from a video posted on its website. While the majority of the product's risk inf...
  • China Probe Into Chromium-Laced Capsules Escalates, 77M Capsules Seized

    Chinese regulatory authorities have announced the expansion of a probe into pharmaceutical capsules illicitly laced with Chromium, saying they have arrested nine more people, detained a further 45 and seized more than 77 million capsules, reports Reuters . Chromium is a heavy metal that has been associated with cancer in some circumstances. Chinese authorities originally announced on 15 April that they had found 13 pharmaceutical products-including antibiotics-to have b...
  • China: China Launches National Campaign Against Counterfeit Drugs

    A national campaign targeting counterfeit drugs was launched on 27 March jointly by the State Food and Drug Administration (SFDA) and Ministry of Public Security through a notice issued to all provinces, autonomous regions, and municipalities.  The notice calls for mutual coordination and cooperation between local food, drug and law enforcement agencies in "combating" the production and sales of counterfeit and inferior drugs.  Local authorities are encouraged...