FDA Policy/General
Truth in Advertising, a non-profit consumer watchdog, says that some of the country’s biggest and most prestigious cancer treatment centers use misleading testimonials that fail to disclose that their results are not typical. NBC News reports that Truth in Advertising found that out of 48 cancer centers, 90%
FDA Policy/General
Federal Register notice: FDA has determined that 47 drug products it is listing were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will not begin procedures to withdraw approval of ANDAs that reference the drug products, and it will allow FDA to
FDA Policy/General
FDA 11/19 responded to a petition to allow a new qualified health claim for edible oils containing high levels of oleic acid, a monounsaturated fat that has cardiovascular benefits when it replaces heart-damaging saturated fat. Product labeling for the oils can state: “supportive but not conclusive scientific evidence
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications” (OMB Control Number 0910-0719), To view the notice, click here.
FDA Policy/General
Annual Report on Post Marketing Requirements/Commitments Federal Register notice: FDA announces the availability of its annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” 11/16/2018 Consumer Reps Needed for Advisory Committees Federal Register notice: FDA seeks consumer organizations
FDA Policy/General
Senator Mike Enzi (R-WY) has written FDA commissioner Scott Gottlieb expressing concern over eventual senior staff turnover and asking for details of the agency’s succession plan. In the 11/14 letter, Enzi asked for details on how the agency is working to “ensure a strong pipeline of leadership
FDA Policy/General
Federal Register notice: FDA has announced the availability of its annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” The report shows that an average of 264 postmarketing requirements (PMRs) were established each year since FY 2011. Most PMRs that were
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. It is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees for which vacancies currently exist or
FDA Policy/General
Federal Register notice: FDA has published a list of PMAs and humanitarian device exemption applications that have been recently approved. The listing serves to inform the public about the availability of related safety and effectiveness summaries through the Internet and the agency’s Dockets Management staff. To view the listing,
FDA Policy/General
Federal Register notice: FDA has announced three public meetings entitled “Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonization (ICH) E2B(R3) Standards.” The meetings are intended to provide the pharmaceutical industry and other interested parties with information on the plans,
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its regulations to implement a provision of the 21st Century Cures Act that would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate
FDA Policy/General
Federal Register notice: FDA has announced a 2/4 public workshop entitled “Evaluating the Pressor Effects of Drugs.” The workshop is intended to bring the stakeholder community together to discuss the premarketing assessment of a drug’s effect on blood pressure. FDA says that elevated blood pressure is known to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.” This form of cancer is defined by rising prostate-specific antigen (PSA) despite castrate levels of testosterone and no radiographic evidence of distant metastatic disease.
FDA Policy/General
Ultragenyx Pharmaceutical has completed a pre-NDA meeting and plans to submit an NDA for UX007 for treating patients with long-chain fatty acid oxidation disorders in mid-2019. The company says the meeting led to an agreement to include data from a Phase 2 company-sponsored study of UX007
FDA Policy/General
FDA says it wants to study the impact of prescription drug professional promotion disclosures as they relate to presentations of preliminary and/or descriptive scientific and clinical data in promotional labeling and advertising for oncology products. An 11/14 Federal Register notice says that the use of disclosures “is one
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on a guidance for “Medical Device User Fee Small Business Qualification and Certification” (OMB Control Number 0910-0508). The document describes the criteria FDA will use to decide whether an entity is eligible for a reduction in user
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Surveys and Interviews With Investigational New Drug (IND) Sponsors To Assess Current Communication Practices With FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI).” As part of PDUFA VI, FDA
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. Approved information collections include “Disclosures in Professional and Consumer Prescription Drug Promotion,” “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads,” “Reclassification Petitions for Medical Devices,” and “Medical
FDA Policy/General
Federal Register notice: FDA has announced a 12/11 public meeting entitled “Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI.” The meeting is intended to fulfill commitments made under the recently reauthorized Prescription Drug User Fee Act and the 21st Century Cures Act by soliciting
FDA Policy/General
Axiron Not Withdrawn Over Safety/Efficacy Federal Register notice: FDA determines that Eli Lilly’s Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn for safety or effectiveness reasons. 11/08/2018 Pilot Survey to Assess Allergy to Cosmetics Federal Register notice: FDA seeks comments
FDA Policy/General
Federal Register notice: FDA has determined that Eli Lilly’s Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn for safety or effectiveness reasons. Axiron was initially approved in 2010 for replacement therapy in males for conditions associated with a deficiency or absence of endogenous
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new proposed information collection entitled “Web-Based Pilot Survey To Assess Allergy to Cosmetics in the U.S.” The proposed pilot study is intended to collect data needed for a current and detailed understanding of the impact of allergens on consumer