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  • JAMA Study Shows Deep Public Mistrust in FDA, Belief Agency is Suppressing Cures

    A new study published in the Journal of the American Medical Association's (JAMA) Internal Medicine portrays worrying information about public trust in the US Food and Drug Administration (FDA). The Study The study, "Medical Conspiracy Theories and Health Behaviors in the United States," sought to investigate public confidence in various medical conspiracy theories that have proliferated in the US over the course of the last 50 years. Study authors Eric Oliver and ...
  • In Transparency Bid, EU Regulators Unleash More Information About Drug Safety Measures

    In the EU, as in the US, regulators often approve medicines along with measures intended to mitigate risks associated with the use of a drug. Background: What's an RMP? The Risk Management Plans (RMPs), as they're called, include information on how to minimize or prevent risk, plans to initiate postmarketing studies on the safety and efficacy of a medicine, studies to measure the effectiveness of risk-mitigation measures, and general information regarding the known r...
  • Endo's Aveed Approved by FDA, Drawing Anger from Consumer Group

    US regulatory officials today approved Endo Pharmaceuticals' testosterone replacement therapy drug Aveed (testosterone undecanoate), ignoring a petition submitted last week by a consumer group that claimed the agency should first conclude a safety review of alternative products. Background FDA recently initiated a safety review of testosterone replacement therapy drugs-more commonly known as "Low-T" drugs-after several studies raised concerns about their cardiovascular ...
  • Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed

    Less than a month after US regulators issued a preliminary warning about the cardiovascular risks associated with products intended to treat low testosterone levels in men, a prominent consumer advocacy group is calling on the US Food and Drug Administration (FDA) to add more serious warnings to the products. Background FDA's review of the products, commonly known as "low-T" drugs, was triggered by two separate studies. The studies, in the  Journal of the American...
  • Feature ArticlesFeature Articles

    Looking to the Future in Regulatory Affairs

    Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and expectations, and discussions with peers in the regulatory community. There are many strands to consider when looking to the future in regulatory affairs. The first strand is the regulations and how these are likely to be impacted by a globalized ...
  • Watchdog Group: FDA Failed to Shut Down Compounder Earlier, at Blame for Outbreak of Infections

    What did government officials know, when did they first know it, and what did they do in response? It's a classic question faced by nearly every agency in the US government, including the US Food and Drug Administration (FDA), which has in recent months been under pressure from legislators regarding its oversight of the pharmaceutical compounding industry. In light of a massive outbreak of fungal meningitis that has since been linked to products manufactured at a Massach...
  • Brazil Opens Consultation on API Manufacturing Change Notifications

    Brazil's National Agency for Sanitary Surveillance (Anvisa) opened a public consultation (Consultation No. 22/13) on 12 July 2013 concerning new requirements for reporting manufacturing changes for active pharmaceutical ingredients (APIs). The proposal provides a classification system as to the types of possible changes and the reporting procedures that should be adopted in each case. The manufacturer would have to notify Anvisa of changes according to the impact on t...
  • FDA Re-Issues Final Guidance on Open Public Hearings, Following Unusual Process

    The US Food and Drug Administration (FDA) has released a new final guidance document regarding open public hearing sessions at the agency's advisory committee meetings, but the process by which it was published is highly unusual under the agency's good guidance practice standards. Background The final guidance, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings , was first issued as a d...
  • Changes Coming to Australian Advertising Rules

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed changes to the current regulatory framework for the advertising of therapeutic goods to the general public. The TGA noted that it is not proposing any changes relating to the advertising of prescription and certain pharmacist-only medicines to the general public, which will remain prohibited in Australia. The objectives of the proposed reforms are to: Improve the timeliness and ...
  • TGA Opens Consultation on Rolling Adoption’ of PIC/S GMP Changes

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on implementing a 'rolling adoption' of new good manufacturing practice (GMP) versions of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S), two international instruments designed to improve co-operation between regulatory authorities and the pharmaceutical industry. The proposal would automatically adopt the new PIC/S changes during a transition p...
  • Public Citizen Blasts Draft Compounding Rules, Says New Category Would Skirt Regulatory Requirements

    A US Senate proposal to overhaul the way in which compounded pharmaceutical products are regulated is being slammed by a prominent public advocacy group, Public Citizen, which claims that the proposed legislation is "a major step backward for US drug safety." Background In the US, pharmaceutical products generally fall into two categories: Those that are manufactured, typically for use by a wide audience, and those that are specifically tailored for a specific individua...
  • Delay in Sending Warning Letter to Fat Loss Device Company Hurt Patients, Group Claims

    A new warning letter sent by the US Food and Drug Administration (FDA) to medical device manufacturer RevecoMED regarding the sale and use of its "LipoTRON 30000" device is bringing both praise and scorn from some industry watchers, who say the device and its manufacturer have long flaunted federal regulations without consequence. Background The device, also known as the RFLipo System (Model DETCBF140), is technically a "therapeutic massager." Under FDA regulations, the...