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  • Appeals Court Says Stem Cells May be Regulated as Drugs, Affirming Low Court's Decision

    The US District Court of Appeals for the DC Circuit has ruled that a lower court was correct when it ruled that the US Food and Drug Administration (FDA) could legally regulate stem cells as drugs. Background In July 2012, the US District Court of DC  ruled  that FDA may legally regulate stem cell therapies as drug products. The decision was viewed by many as an opening salvo in what was likely to be a lengthy court battle between the agency and a company accu...
  • FDA Challenges Another Company's Interpretation of HCT/P Regulations, Leading to Delays

    On 6 September 2013, the US Food and Drug Administration (FDA) released an Untitled Letter to a manufacturer of amniotic/chorionic-based products, saying it had run afoul of "minimal manipulation" regulations under 21 CFR 1271. Now the company is in effect conceding to FDA's contentions, suspending enrollment in a US-based clinical trial meant to support an eventual regulatory filing and commercialization of its products. Background On 5 September 2013, FDA's Center for...
  • Lawsuit: FDA Tissue Donation Regulations 'Unconstitutional'

    A woman is suing the US Food and Drug Administration (FDA) over its policy requiring potential sperm donors to undergo health testing before being allowed to donate, calling the regulations a violation of her constitutional rights. At issue for the woman-an Oakland, California resident known only as "Jane Doe" in the court filings-is whether she can use a trusted male friend as a sperm donor so she may start a family with her female partner without the interference of th...
  • Feature ArticlesFeature Articles

    Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices

    This article reviews the current state of the development of quality system requirements for combination products, in particular prefilled drug delivery devices. As part of a series on US Food and Drug Administration (FDA) regulation of combination products, 1-9 it discusses industry's response to FDA's proposed rule on quality systems for combination products and how manufacturers of combination products should prepare for compliance with the anticipated final rule and ...
  • FDA Warning Letter Cites Company for Breaking HCT/P Regulations

    A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells, tissues or cellular and tissue-based products (HCT/Ps). FDA's warning letter specifically cites Young's Owner and Medical Director Thomas E. Young for removing, reprocessing and injecting patients with their own adipose tissue (lipoaspirate), from which Young isolated stem ce...
  • Implementation of Medical Device Recall Authority Sought by FDA

    The US Food and Drug Administration (FDA) announced on 10 February that it is seeking to implement its medical device recall authority under § 518(e) of the Federal Food, Drug and Cosmetic Act (FD&C Act) and Chapter 21, Section 810 of the Code of Federal Regulations (CFR). Section 518(e) allows FDA to order manufacturers to cease distribution of a device and notify health professionals if FDA finds a "reasonable probability that the device intended for human...