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  • Regulatory NewsRegulatory News

    Two more stem cell firms slapped with untitled letters

    Untitled letters issued to two firms for marketing unapproved stem cell products signal that some in the industry are undeterred by the US Food and Drug Administration’s (FDA) efforts to get these products approved or off the market.       The letters join four others from the Center for Biologics Evaluation and Research (CBER) in recent months to clinics marketing unapproved stem cell products after an enforcement grace period ended on 1 June. (RELATED: CBER targets...
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    FDA to Amazon: Stop shipping products that contain undisclosed drugs

    The mammoth online retailer Amazon received an untitled letter from The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) identifying 26 sexual enhancement and weight loss products that contain “undeclared” and “potentially harmful” drug ingredients, according to FDA’s testing of the products.   In this letter — not the first correspondence the agency has had with Amazon on the matter —the firm was called out for marketing unapprove...
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    OPDP sends first untitled letter of 2020 to Xeris over Gvoke TV spot

    Xeris Pharmaceuticals last week received the first untitled letter sent by the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) in 2020 over claims made in a television ad for its Gvoke (glucagon) pre-filled syringe.   The letter is only the second enforcement letter sent by OPDP this year after the office warned Outlook Pharmaceuticals for omitting risk information in a sponsored link on Google, marking a particularly light year for...
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    FDA Questions Arizona Stem Cell Company

    As part of efforts to crack down on companies selling unapproved stem cell products to treat a variety of diseases and conditions, the US Food and Drug Administration (FDA) on Thursday sent an untitled letter to Arizona-based R3 Stem Cell and its more than 50 affiliate centers or clinics. FDA raises concerns with R3 because its website makes unsubstantiated claims about the stem cell products, which FDA says appear to be human cell, tissue, or cellular or tissue-based p...
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    CBER Sends Untitled Letter to Marketer of Unapproved Allergy Spray

    The US Food and Drug Administration’s (FDA) Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) sent an untitled letter to the owner of two websites purporting to sell allergy treatments that have not been approved.   The company Telogenes, LLC boasts that its product, known as Ollereg, “contains FDA-approved allergens used off label for oral immunotherapy,” among other claims, but FDA raised concerns.   “Based on t...
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    OPDP Issues Third Warning of 2017

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) this month issued its third warning or untitled letter of the year to Kentucky-based Magna Pharmaceuticals because its webpage and panels from a conference exhibit made false or misleading claims about the risks associated with and efficacy of its insomnia treatment Zolpimist (zolpidem tartrate). FDA said both Zolpimist’s webpage , supported by Amherst Pharmaceuticals, and exh...
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    FDA Cracks Down on TV Ad for Prescription Weight Loss Drug

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent its first untitled letter of 2017 to Orexigen Therapeutics for a television advertisement that created a misleading impression about the safety of the weight loss drug Contrave (naltrexone HCl and bupropion HCl). OPDP found the ad , which opens with groups of women simulating a brain, contained efficacy claims for Contrave, but failed to include important risk information....
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    FDA Warns Boston Company for Selling Unapproved Biologic to Prevent Peanut Allergies

    The US Food and Drug Administration’s (FDA) Office of Compliance in Biologics Quality in the Center for Biologics Evaluation and Research (CBER) on Monday released an untitled letter sent to Cambridge, MA-based Antera Therapeutics because it's selling an unapproved biologic intended to prevent a peanut allergy. According to the letter dated 16 November to Antera CEO Clarence Friedman, a Harvard Business School graduate in 2015 and former senior associate scientist at P...
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    FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) earlier this week sent a letter to Rockville, MD-based Supernus Pharmaceuticals noting that one of its promotional videos makes false or misleading claims and/or representations about the risks associated with Oxtellar XR (oxcarbazepine). The letter, the fifth of which was issued this year by OPDP (the last one was issued in September), focuses on the video’s use of the general terms “e...
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    Promotional Materials at ASCO Land Jazz Subsidiary FDA's Third Untitled Letter of 2016

    In just its third untitled letter of the year (and the first in almost five months), the US Food and Drug Administration (FDA) on Tuesday called out Jazz Pharmaceuticals subsidiary Celator Pharmaceuticals for promoting an investigational drug in a panel at the American Society of Clinical Oncology’s (ASCO) annual meeting in June. The company promoted the investigational drug, which was previously granted a breakthrough therapy designation by FDA, with claims that it is...
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    FDA Sends Untitled Letter to Danish Drugmaker Over GMP Issues

    The US Food and Drug Administration (FDA) has issued an untitled letter to Danish allergy immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter, dated 15 July 2016, comes after a 12-day inspection of the facility in March 2016, during which FDA investigators cited ALK for four "significant deviations" from current good manufacturing practice (cGMP) requirements. Additionally, FDA says that some ...
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    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, ...