Devices
After failing to convince FDA commissioner Stephen Hahn that the agency should give up its responsibility for evaluating the safety and accuracy of laboratory-developed Covid-19 tests, HHS secretary Alex Azar took the matter into his own hands and revoked FDA’s ability to evaluate the tests. In an
Drugs
FDA has announced a 10/30 virtual public workshop on “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” The event is intended to solicit public feedback on characteristics of the integrated review document and how the integrated assessment can continue to
Devices
An update on the status of the FDA software precertification program indicates the evaluation of the pilot program will continue, apparently with no additional pilot participants and no indication that the program will be operational any time soon. Attorneys Allison Fulton and Julia Kadish (SheppardMullin) write in their firm’s
Devices
FDA has classified as Class 1 a recall involving a Becton Dickinson CareFusion recall of its Alaris Syringe and Alaris PCA Modules due to potential incorrect display of syringe types and sizes. A recall notice says the display errors could result in delays in infusion, under-infusion, or over-infusion,
Biologics
CBER has updated its calendar year 2020 guidance agenda listing 29 guidances the Center plans to publish this year. The agenda lists 14 planned guidances under Blood and Blood Components, 10 under Tissues and Advanced Therapies, two under Vaccines, and three under Other.
Devices
FDA has approved GE Healthcare’s shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI contrast agent, Clariscan (gadoterate meglumine). The bulk package is designed to reduce the risk of breakage and injury from broken glass, the company says, adding that injuries associated with glass
Drugs
The Alliance for Regenerative Medicine says CBER was under-represented in an independent third-party review assessment of FDA-sponsor communication practices during the IND stage of new drug/biologic development. The group says that “in light of the resource constraints and staggering number of active INDs with CBER,” FDA
FDA Policy/General
An Axios/Ipsos poll conducted on 9/11-9/14 finds that fewer than 10% of Americans have a great deal of trust in FDA or in drug companies to look out for their interests. The firms say the poll results show how difficult it may be to get Americans
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Kalchem International, Lindsay, OK (8/27): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals and active pharmaceutical ingredients (APIs). For example, Kalchem failed
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a radio ad for Sprout Pharmaceuticals’ Addyi (flibanserin) tablets makes false or misleading claims about the drug’s risks and omits other material facts. An 8/31 Warning Letter says the violations “are concerning from a public health perspective because they
Drugs
A 2/10-2/21 FDA inspection at Kalchem International, Lindsay, OK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API). An 8/27 Warning Letter says specific issues were: * failing to have, for each batch
FDA Policy/General
Federal Register notice: FDA has announced that it issued a priority review voucher to Vertex Pharmaceutical for Trikafta (elexacaftor/tezacaftor/ivacaftor), indicated for treating patients with cystic fibrosis aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene. To view
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards; Guidance for Industry and Food and Drug Administration Staff. The document identifies the principles FDA uses for recognizing a standard, and it explains the extent of recognition and other supplementary information. To
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB under the Paperwork Reduction Act of 1995. To view the notice, click here.
Drugs
FDA has published a draft guidance, Geriatric Information in Human Prescription Drug and Biological Product Labeling, to assist applicants in determining the appropriate placement and content of geriatric information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.
Drugs
A 2/17-2/20 FDA inspection at the Mayon’s Pharmaceuticals facility in Nagpur, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API). A 9/4 Warning Letter says specific violations were: * failing
FDA Policy/General
Former Microsoft CEO Bill Gates says FDA and CDC are casualties of the Donald Trump presidency that has downplayed or dismissed science and medicine in the pursuit of political gain. Interviewed by Bloomberg Television, Gates cited FDA commissioner Stephen Hahn’s rapid about-face on the benefit of convalescent plasma
Drugs
FDA has issued Mallinckrodt a complete response letter on its NDA for terlipressin and its use in treating adults with hepatorenal syndrome Type 1 (HRS-1). The letter said that, based on the available data, the agency cannot approve the NDA in its current form and it requires more information
FDA Policy/General
Federal Register notice: FDA is requesting that stakeholders notify it about their intent to participate in periodic consultation meetings on reauthorizing the Generic Drug User Fee Amendments of 2017 (GDUFA). At the end 9/2022, new legislation will be required for FDA to continue collecting user fees for subsequent fiscal
Devices
FDA has published a final guidance entitled Recognition and Withdrawal of Voluntary Consensus Standards. The document outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard. According to the guidance, FDA: * Will publish its justification for recognition and
Devices
FDA has released an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning toward a “question-based approach” for its tested streamlined review which it believes will lead to a structured and consistent “ software as a medical device (SaMD)” definition in
Devices
Becton Dickinson CareFusion 303 has recalled its Alaris System Infusion Pumps due to damaged inter-unit interface connectors, loose or missing battery screws and broken upper and lower hinge posts and membrane frame. A damaged inter-unit interface connector may lead to interruption of communication or power between the PC