FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Coupler Enterprises, Warrington, PA (9/15): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Coupler failed to inspect the packaging and
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Investigational Covid-19 Convalescent Plasma.” On 8/23, the agency issued an emergency use authorization for convalescent plasma that requires the guidance’s replacement. The new document includes a discussion to facilitate the availability of investigational convalescent plasma when
FDA Policy/General
Federal Register notice: FDA has withdrawn a May-issued final guidance entitled “Investigational COVID–19 Convalescent Plasma” because the agency is issuing a new guidance under the same title. On 8/23, the agency issued an emergency use authorization for convalescent plasma that made the guidance obsolete. To view the
FDA Policy/General
Consumer Organizations Sought for Advisory Panel Selections Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels. 09/18/2020 Info Collection on Social Behavioral Sciences Data Federal Register notice: FDA seeks comments on a
FDA Policy/General
Molecular diagnostics company Biodesix has acquired Seattle-based Integrated Diagnostics on undisclosed terms. The transaction includes Integrated’s lead oncology product, XL2 test, which is intended to rule out cancer for patients with suspicious lung nodules. Becton, Dickinson and Co. has completed its acquisition of TVA Medical, which develops vascular
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion.” The proposed research involves assessing how consumers and primary care physicians interpret terms and phrases commonly used in prescription drug promotion, as well as those used
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed study entitled “Medical Conference Attendees’ Observations About Prescription Drug Promotion.” The study is intended to focus on understanding the landscape of healthcare provider-directed promotion of prescription drugs at medical conferences and how elements of pharmaceutical booths in medical conference
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed “Survey of Drug Product Manufacturing, Processing and Packing Facilities — 21 CFR parts 210 and 211.” The agency says the survey is intended to help it better understand how manufacturers, processors, and packers of drug products approach managing risks related to
FDA Policy/General
House Energy and Commerce Committee leadership has denounced the White House after it blocked FDA commissioner Stephen Hahn from testifying before the committee this month about potential political interference into Covid-19 response efforts. “The American people deserve to hear Commissioner Hahn’s response to those concerns during a public
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is planning to question healthcare providers about their view of prescription drug promotion in exhibit halls at medical conferences. A Federal Register notice says the research will look specifically at how elements of pharmaceutical booths in medical conference exhibit halls affect healthcare
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify Class 3 cytomegalovirus deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management into Class 2 (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “quantitative cytomegalovirus nucleic acid
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of two Eisai NDAs for Belviq (lorcaserin HCl) tablets and Belviq XR (lorcaserin HCl) extended-release tablets, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in certain adults. In 2019, FDA issued a
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to AstraZeneca for an approved rare pediatric disease product — Koselugo (selumetinib), indicated for treating pediatric patients two years of age and older with neurofibromatosis Type 1 who have symptomatic, inoperable plexiform neurofibromas. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Geriatric Information in Human Prescription Drug and Biological Product Labeling. The document provides recommendations to help ensure that appropriate geriatric information is consistently placed in the proper sections and subsections within labeling. It also provides examples of geriatric use
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment. The document addresses the agency’s current thinking about clinical trials and development programs for such drugs, including recommendations for the necessary attributes of patients for enrollment, trial design, efficacy considerations, safety assessments,
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
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.
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