• Regulatory NewsRegulatory News

    Trump HHS advisor pressured FDA, says House subcommittee

    The House Select Subcommittee on the Coronavirus Crisis on Monday released nearly 100 pages of emails underscoring political pressure from a Trump administration official who pushed for the authorization of hydroxychloroquine and convalescent plasma to treat COVID-19.   Citing the emails, Subcommittee Chairman James Clyburn (D-SC) wrote to White House Chief of Staff Ronald Klain and Acting Health and Human Services Secretary Norris Cochran seeking additional docume...
  • Regulatory NewsRegulatory News

    FDA narrows convalescent plasma EUA

    The US Food and Drug Administration (FDA) on Thursday revised its emergency use authorization (EUA) for COVID-19 convalescent plasma to limit its use to high titer units and only in hospitalized patients who are in the early stages of the disease or who have impaired humoral immunity.   Convalescent plasma emerged as a potential treatment for COVID-19 in the early months of the pandemic. Initially, FDA facilitated its use through single patient emergency investigationa...
  • Regulatory NewsRegulatory News

    FDA explains convalescent plasma donor eligibility for COVID vaccine recipients

    The US Food and Drug Administration (FDA) last week revised its guidance on COVID-19 convalescent plasma to clarify when COVID-19 vaccine recipients can qualify as donors for plasma collected under the agency’s emergency use authorization (EUA) for convalescent plasma.   (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA , Regulatory Focus 25 August 2020; COVID convalescent plasma guidance gets EUA updates , Regulatory Focus 3 Septembe...
  • Regulatory NewsRegulatory News

    Lawmakers, experts raise questions after convalescent plasma EUA

    After US Food and Drug Administration (FDA) Commissioner Stephen Hahn announced the issuance of an emergency use authorization (EUA) for convalescent plasma to treat coronavirus disease (COVID-19) alongside President Donald Trump on Sunday, experts and democratic lawmakers are raising concerns about how the announcement was presented and the perception of political pressure on the agency.   Convalescent plasma appears to meet the statutory standards for an EUA, which o...
  • Regulatory NewsRegulatory News

    FDA Identifies ARBs Without Impurities

    For the first time since the US Food and Drug Administration (FDA) discovered a nitrosamine impurity in angiotensin II receptor blockers (ARBs) last summer, the agency has now identified 40 ARBs and counting that do not contain a nitrosamine impurity. “Our goal is for this information to help health care providers as they consider acceptable treatment options for their patients,” outgoing FDA Commissioner Scott Gottlieb and CDER Director Janet Woodcock said in a joint s...
  • Regulatory NewsRegulatory News

    EMA Follows FDA Warning on Xeljanz Blood Clot Risks

    The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.   EMA’s warning comes less than a month after the US Food and Drug Administration (FDA) issued a similar warning after identifying the risk during an ongoing postmarketing safety study for the drug. In the lat...
  • Regulatory NewsRegulatory News

    FDA Warns Cord Blood Marketer, Reiterates Enforcement Discretion

    The US Food and Drug Administration (FDA) on Thursday released a warning letter sent late last month to San Diego-based umbilical cord blood product producer Genetech for selling unapproved products. The warning letter comes as FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products and subsequently became ill due t...
  • Regulatory NewsRegulatory News

    FDA and Pentagon Forge Breakthrough Designation Agreement

    Following the Pentagon’s criticism of the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have used for years, FDA and the Department of Defense’s (DoD) Office of Health Affairs on Tuesday launched a joint program to prioritize the efficient development of such medical products. The framework for the program was established, via H.R.4374 , after DoD sought to crea...
  • Regulatory NewsRegulatory News

    FDA Finalizes Chagas Disease Guidance for Blood Collection Establishments

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the use of serological tests to reduce the risk of transmission of T. cruzi , a parasite that causes Chagas disease, in blood and blood components. This guidance supersedes 2010 guidance and finalizes a draft from 2016 that amended the 2010 guidance by expanding its scope to include the collection of blood and blood components for use in manufacturing a product, including donations intende...
  • Regulatory NewsRegulatory News

    Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

    As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans. The deal was forged after Theranos said it ultimately had to void or correct over 830,000 test results, which was about 11% of all results. A day earlier, Theranos announced it would settle with the federal Centers for Medicare & Medicaid Se...
  • Regulatory NewsRegulatory News

    FDA Calls Out Unproven Claims of Unapproved Blood Device

    Earlier this month, the US Food and Drug Administration (FDA) released a letter sent to Dr. PRP America for claims made on its website for an unapproved medical device that the San Diego-based company claims can help concentrate and extract blood platelets, as well as adjust blood plasma levels. Mary Malarkey, director of the Office of Compliance and Biologics Quality at FDA’s Center for Biologics Evaluation and Research, wrote in the letter that a review of FDA’s databa...
  • Regulatory NewsRegulatory News

    FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems

    • 07 October 2016
    The Food and Drug Administration (FDA) on Friday finalized two guidance documents related to blood glucose monitoring systems (BGMSs), offering new recommendations on the different types of information in 510(k)s for BGMSs used by health professionals versus SMBGs intended for home use by lay users. FDA says the guidance was necessary as it has become increasingly clear that these different use settings have distinct intended use populations with unique characteristics...