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  • Regulatory NewsRegulatory News

    How Often Does FDA Withdraw Drugs Using Discontinuation Petitions? Very Rarely

    Not all drugs approved by the US Food and Drug Administration (FDA) stand the test of time. In some cases, the drugs are eventually removed from the market, either because they are unsafe, ineffective or just because their sponsor no longer feels like making them. But how often do these withdrawals take place, and to what extent do they reflect concerns about the safety or efficacy of a drug? Background The question is the subject of a new analysis by Hyman, Phelps & Mc...
  • Regulatory NewsRegulatory News

    Is a Drug Unsafe or Just Unprofitable? How a Lack of Data Clouds Regulatory Classifications

    Regulatory professionals are frequently concerned with getting pharmaceutical products approved for use and available to consumers. But as a new paper in the Journal of the American Medical Association (JAMA) explains, the way in which drug products are withdrawn from the market can have significant implications for both regulators and patients as well. Background Writing in JAMA Internal Medicine , Vinay Prasad, an official associated with Johns Hopkins University...
  • Regulatory NewsRegulatory News

    Three Years After Warnings, FDA Bans Last High-Dose Aceptaminophen Products

    All prescription drugs containing high doses of acetaminophen have officially been withdrawn from the market, the US Food and Drug Administration (FDA) indicated in a regulatory filing this morning. Background In January 2011, FDA requested that manufacturers discontinue marketing high-dose versions of acetaminophen—defined as doses higher than 325 mg—due the drug causing severe liver failure in some patients. "Overdose from prescription combination products containi...
  • FDA's New Veterinary Antibiotics Strategy Yields Early Results

    Several months after first launching a new regulatory approach intended to voluntarily limit the prescribing of non-essential antibiotics in food-producing animals, the US Food and Drug Administration (FDA) is already seeing success. Background FDA's antibiotic use policy  first began to take shape  in the 1970s, and in recent years has been subject to intense scrutiny from outside  advocates ,  former FDA officials ,  government investigators ,...
  • FDA Announces Planned Withdrawal, Revision of Dozens of Guidance Documents

    Got a gripe with an older draft guidance document? Now might be the time to air that grievance, with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) announcing that it plans to conduct a retrospective analysis of all guidance documents issued prior to 2010 with the intent of withdrawing unnecessary documents or revising any documents in need of changes. A New Initiative Writing in the 7 August 2013 edition of the Federal Regis...
  • Purdue's NDA for Oxycontin Formally Withdrawn as FDA Closes Route to Generic Competitors

    The US Food and Drug Administration (FDA) has announced the withdrawal of a new drug application (NDA) for Purdue Pharma's Oxycontin (NDA #20-553), the very same application that had lost patent protection in April 2013 and had been subject to potential generic competition before FDA said it would not approve any non-abuse-resistant formulations of the drug. Background Under current regulatory policy, approved drugs products are protected by several types of statutory p...
  • In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program

    If you're waiting for the US Food and Drug Administration's (FDA) guidance on planned changes to its medical device pre-submission meeting program, you may have to wait a bit longer. In a highly unusual Federal Register notice on 4 January 2013, FDA explained that it was withdrawing an earlier 11 December 2012 Federal Register notice in which it announced that it had submitted for review the guidance document The Pre-Submission Program and Meetings with FDA Staff ...
  • Citing a Change in Thinking, FDA Withdraws Lupus Product Guidance

    The US Food and Drug Administration (FDA) said it is withdrawing a guidance document published in June 2010 in light of the document no longer reflecting its current thinking on the topic. In its 26 June 2012 Federal Register posting, FDA said its guidance, " Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing Medical Products for Treatment ," was being withdrawn immediately. Systemic Lupus Erythamatosus is an autoimmune disease in which the body's immun...
  • Pfizer Withdraws Indication for RA Drug After It Fails to Complete Required Study

    The US Food and Drug Administration (FDA) said Pfizer is withdrawing an indication for its rheumatoid arthritis (RA) drug Celebrex after Pfizer indicated it would not be able to complete a mandated postmarketing study to verify the new indication. Celebrex had received approval for its indication to treat familiar adenomatous polyposis (FAP) in 1999 under FDA's accelerated approval pathway. The inherited condition causes polyps to form in the large intestine, often causi...