• Consumers Groups Attack FDA Over De Novo Process

    A group of 12 consumer groups is chastising the US Food and Drug Administration (FDA) for approving what they perceive to be 'high-risk' medical devices through FDA's de novo approval pathway . In a letter to FDA Commissioner Margaret Hamburg sent 29 February, the groups, including Consumers Union and Public Citizen, said that FDA's use of the de novo pathway was setting a bad precedent. "Medical devices intended to save lives should require FDA's most rigorous saf...
  • FDA Rebuffs Attempt to Delay Generic Drugs By Scoring Pills

    Pharmaceutical manufacturer Warner Chilcott's attempt to delay generic competition for its Doryx acne pill has been rebuffed by the US Food and Drug Administration (FDA), according a response letter posted by the agency . Warner Chilcott had changed the scores on its Doryx tablets from one score to two scores. The scores are used by physicians and patients to properly split the pills. Warner Chilcott's change, it argued, was substantial enough that any generic manufactu...
  • Proposed FDA Rule Would Amend Citizen Petition Regulations

    On 3 January the US Food and Drug Administration (FDA) released a new proposed amendment via the US Federal Register that would amend the regulations governing the process for citizen petitions, petitions for stay of action, and the submission of documents to the FDA. The proposed rule would amend the way the FDA deals with section 505(q) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which regulates how the FDA responds to citizens petitions and petitions ...