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  • Feature ArticlesFeature Articles

    21 CFR Part 11: The Ins and Outs of One of FDA's Most Difficult Rules

    Introduction 1992 was a different time, when the Internet was still in its infancy and email as a corporate tool was only just beginning to take hold. In the life science industry, there were dreams—then unrealized—of a completely electronic and totally paperless office. And at the US Food and Drug Administration (FDA), regulators were only just beginning to realize the potential effects digital data management systems could have on product development. It was around th...
  • Regulatory NewsRegulatory News

    It's Not Just You: FDA Regulatory Requirements Really Are Increasing

    The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year. According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus , the number of regulatory requirements...
  • Regulatory NewsRegulatory News

    Recall or Removal? New FDA Device Guidance Clarifies Murky Definitions

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has finally put the finishing touches on a controversial guidance regarding how to distinguish the recall of a device from a market withdrawal. Background On 21 February 2013, FDA released a draft guidance document aimed in part at establishing the requirements for distinguishing between defect- or failure-based recalls and products recalled for improvements or "enhancements." ...
  • Regulatory NewsRegulatory News

    FDA Extends UDI Compliance Date for Most Contact Lenses

    Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry. Background A UDI is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulators. "The unique device identification system will h...
  • Regulatory NewsRegulatory News

    FDA Classifies Cellulite-Reducing Device as Class II

    The US Food and Drug Administration (FDA) has announced that it will soon classify surgical instruments intended to improve "the appearance of cellulite" as Class II medical devices, making it easier for them to be brought to market. Background In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices) Class II (moderate-risk devices) Class III...
  • "Our Lady's Tears" Brings Warning Letter to Supplement Maker

    If you didn't know better, seeing an ingredient on a dietary supplement labeled as "Our Lady's Tears" might make you think the manufacturer's process involved forcing a woman to cry into a batch of ingredients destined for further processing. And that, the US Food and Drug Administration (FDA) explained in a Warning Letter recently posted on its website, is a problem-for the manufacturer, that is. FDA's 21 March 2014 Warning Letter to Florida-based Aloe Man Internation...
  • Feature ArticlesFeature Articles

    Data Integrity in the FDA-Regulated Laboratory

    "Data integrity problems break trust. In the time between inspections, we trust you to do the right thing. And if we finish an inspection and that trust has been broken, then we need to go through a few exercises to build that trust [again] before we can go forward and trust you until the next inspection."-FDA Center for Drug Evaluation and Research (CDER) Office of Compliance Senior Policy Advisor Karen Takahashi To assure the quality of raw materials, in process mate...
  • UDI Implementation Still on the Horizon, FDA Updates List of Devices Which Must Be Tracked

    A new guidance document released by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) updates the agency's list of devices that manufacturers are required to track by law. Background In 1997, the Food and Drug Administration and Modernization Act (FDAMA) was signed into law. Among the law's numerous requirements is one that manufacturers track specified devices at the order of FDA. The statute, codified in the Federal Food...
  • FDA Moves Ahead With Plan to Make Device Recall and Removal Reporting More Efficient

    In June 2013, the US Food and Drug Administration (FDA) indicated that it was interested in making it easier to submit so-called "806 reports"-filings made to report the removal or correction of a medical device from the market for reasons related to human safety. Now the agency is moving forward with that proposal, submitting it this week for final government review. Background Under  21 CFR 806.10 , companies are required to make written "reports of corrections...
  • Data Show Varied Use, Success of FDA's Expanded Access Program

    In recent years, much attention has been focused on the pharmaceutical industry and its use-and non-use-of the US Food and Drug Administration's (FDA) expanded access program. But how much success has it had? Background That program, sometimes referred to as the "compassionate use" program, allows patients to access experimental treatments they might otherwise not be eligible to receive. For a full explanation of the program, please see our Regulatory Explainer on ...
  • Company Fails to Pass FDA ‘Smell’ Test--Literally

    Of all the ways to validate the identity and quality of ingredients used during the course of manufacturing, using your nose isn't among the most advisable. That piece of wisdom was included in a recent Warning Letter sent by the US Food and Drug Administration (FDA) to a manufacturer of dietary supplements, NJ-based Herbalist and Alchemist, Inc . FDA's letter indicates that the regulator had inspected the company between 22 October and 16 November 2013, during which t...
  • GMP Deficiencies in Spotlight in Warning Letters to Amgen, Baxter

    Life science manufacturing giants Baxter Healthcare and Amgen were each sent Warning Letters by the US Food and Drug Administration (FDA) in January 2014 chiding them for medical device manufacturing problems at their respective facilities. Amgen Letter The Amgen letter refers to a June 2013 inspection of the company's Thousand Oaks, CA facility where it makes three products: Prolia with prefilled syringe and manual needle guard Enbrel lyophilized vial and diluent ...