FDA Policy/General
Legislation proposed by Rep. Rosa DeLauro (D-CT), chair of the House Appropriations Committee, and Sen. Dick Durbin (D-IL) would remove food safety from FDA’s list of responsibilities by creating a separate Food Safety Administration. In a statement (includes links to the bill text and a fact sheet)
FDA Policy/General
FDA commissioner Robert Califf wants to see evidence generation greatly improved during his tenure as the agency’s chief executive, a tenure that he foreshadowed will likely run through the end of the current Administration. Speaking during an Alliance for a Stronger FDA online fireside chat 7/12, Califf said
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for AbbVie’s Rinvoq (upadacitinib), indicated for treating adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The review period is 2,604 days, of which 2,
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a draft guidance entitled “Risk Management Plans to Mitigate the Potential for Drug Shortages.” Comments can now be submitted by 8/31. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is revoking an Emergency Use Authorization issued to Fresenius Kabi USA for its Fresenius Propoven 2% Emulsion and its use during the Covid-19 emergency. The company requested the revocation because the product is no longer being made available in the U.S. To view the
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 31 ANDAs from multiple applicants. The applicants notified the agency that the drug products were no longer marketed and requested they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is correcting the docket number associated with a 6/30 notice on a draft guidance entitled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” To view the notice, click here.
FDA Policy/General
FDA Webview has posted the Federal Register notices that published during the week of our annual Fourth of July (Independence Day) holiday break. 7/8/2022 Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Astellas Pharma and Seagen’s Padcev (enfortumab vedotin-ejfv)
Drugs
U.S. Rep. Abigail Spanberger (D-VA) has introduced a bill entitled the Banning Misleading Drugs Act that is intended to prevent manufacturers from obscuring dangerous side effects of their prescription drugs in their advertisements and to help consumers make informed decisions. The measure would require FDA to finalize a
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of Xellia Pharmaceuticals’ ANDA for bacitracin for injection, 50,000 units/vial, after the company requested it be withdrawn. The intramuscular antibiotic is used for treating infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. The
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels. The agency is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Rhythm Pharmaceuticals’ Imcivree (setmelanotide acetate), indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or
FDA Policy/General
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 11. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from Class 3 to Class 2 (special controls), subject to premarket notification. For such devices, FDA is also proposing a new device classification regulation with the name “computer-aided devices which provide
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled ‘‘Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” The document describes how stakeholders such as patients, caregivers, researchers, medical product developers and others, can collect and submit patient experience data and other relevant
FDA Policy/General
Federal Register notice: FDA has determined that Janssen Pharmaceuticals’ Micronor (norethindrone tablets), indicated for preventing pregnancy, was not withdrawn for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference this product if all other legal and regulatory requirements are met. To view the notice,
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Horizon Therapeutics’ Tepezza (teprotumumab-trbw), indicated for treating thyroid eye disease. The review period is 2,958 days, of which 2,760 days occurred during the testing phase and 198 days occurred during the approval
Drugs
Janssen says a plan by the CDER Office of Prescription Drug Promotion to study how patients and doctors value different aspects of medical product labels “is invaluable in improving clinical care by assessing both what patients and physicians value when considering medical products and how these values may lead to
FDA Policy/General
FDA commissioner Robert Califf has announced that former Johns Hopkins School of Medicine professor Namandjé N. Bumpus has joined the agency as its new chief scientist, and former White House Covid Response Team member Hilary D. Marston has been named chief medical officer. As chair of Johns Hopkins’ Department of
FDA Policy/General
Federal Register notice: FDA has determined for patent restoration purposes the regulatory review period for ViiV Healthcare’s Rukobia (fostemsavir tromethamine), indicated in combination with other antiretrovirals for treating HIV–1 infection in heavily treatment-experienced adults. The review period is 5,322 days, of which 5,110 days occurred
FDA Policy/General
Federal Register notice: FDA has determined for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics’ Danyelza (naxitamab-gqgk), indicated for use in combination with granulocyte-macrophage colony-stimulating factor for treating pediatric patients one year of age and older and adult patients with relapsed or refractory
FDA Policy/General
A Duane Morris Legal Alert says a Department of Justice (DoJ) Statement of Interest filed in a Florida federal court in a Trividia Health whistleblower case makes clear the department’s decision to reawaken a theory of liability thought to be dead. The alert says the fraud-on-FDA theory