FDA Policy/General
President-elect Donald Trump’s top health advisor Robert F. Kennedy Jr. is continuing his criticism of FDA and officials working there, going as far as saying that there a some “departments” and “some categories of workers” that have to go because they are not doing their job. The former
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” and the supplemental document entitled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Questions and Answers.” The International Council for Harmonization-developed document describes the scientific and technical aspects
FDA Policy/General
Federal Register notice: FDA is making available additional revised draft product-specific guidances that provide product-specific recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
FDA Policy/General
Former president Donald Trump appears to be elevating former presidential candidate and now supporter Robert F. Kennedy, Jr’s role in his new administration if Trump wins the upcoming election. In September, Kennedy told former Fox News talk show host Tucker Carlson that he had been asked by Trump to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Antimicrobial Animal Drug Sales and Distribution — 21 CFR 514.87.” The collection helps support the agency’s requirements for new animal drugs containing an antimicrobial active ingredient. Sponsors of animal drugs containing an antimicrobial active ingredient are
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications, abbreviated new animal drug applications, and conditionally approved new animal drug applications made during April, May, and June. They are also being amended to improve their accuracy and readability. To
FDA Policy/General
Federal Register notice: FDA is announcing a 12/4 Pharmacy Compounding Advisory Committee meeting to discuss various bulk drug substances being considered for inclusion on the agency’s 503A bulk drugs listing. Section 503A of the Federal Food, Drug, and Cosmetic Act describes the conditions that must be satisfied for
FDA Policy/General
An FDA safety alert is warning about Regener-Eyes manufactured by Regenerative Processing Plant because the drops likely contain amniotic fluid. The agency says it has received two adverse event reports about “shooting pain in the eyes: after using Regener-Eyes, an ophthalmic drug product marketed for dry eye conditions.
FDA Policy/General
Federal Register notice: FDA is announcing a 12/12 Vaccines and Related Biological Products Advisory Committee meeting. Committee members are scheduled to discuss considerations for respiratory syncytial virus (RSV) vaccine safety in pediatric populations. They will also hear overviews of CBER’s Laboratory of Immunoregulation and Laboratory of Retroviruses research
FDA Policy/General
FDA is planning research to consider the influence of statements around patient adherence and preference in prescription drug promotion. A Federal Register notice says it isn’t known how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers prefer
FDA Policy/General
FDA commissioner Robert Califf says FDA is “entering an era where we’re going to have to rethink everything we do because of the technology changes that we’re seeing, which affect every single industry that we’re dealing with.” As reported by Chief Healthcare Executive, Califf spoke to the
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 9/20 notice on a draft guidance entitled “Chemical Analysis for Biocompatibility Assessment of Medical Devices” that recommends methodological approaches for chemical analysis for devce biocompatibility assessments. Electronic or written comments on the draft guidance can now be submitted
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Pfizer’s Vyndaqel (tafamidis meglumine), indicated for treating cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. The regulatory review period is 4,978
FDA Policy/General
Republican members of the House Energy and Commerce Committee have asked Health and Human Services inspector general Christi Grimm to assess the adequacy of FDA’s oversight and support of its Office of Laboratory Safety (OLS). The request follows a decade-old investigation into the 2014 discovery of boxes containing
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Pfizer’s Vyndamax (tafamidis), indicated for treating cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. The regulatory review period is 4,978 days, of
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Postoperative Nausea and Vomiting: Developing Drugs for Prevention.” The document provides recommendations on the design of drug clinical trials for preventing postoperative nausea and vomiting in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Core Patient-Reported Outcomes in Cancer Clinical Trials.” The document provides recommendations on the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. It focuses
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry.” The document provides a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful in supporting
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 9/23 notice about three draft guidance documents related to CDRH’s Accreditation Scheme for Conformity Assessment Program. Electronic or written comments can now be submitted until 12/23. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Requests for Reconsideration at the Division Level Under GDUFA.” The document provides recommendations on the procedures for ANDA applicants who choose to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.
FDA Policy/General
FDA commissioner Robert Califf and two agency colleagues say that historic advances in artificial intelligence (AI) applied to biomedicine and healthcare “must be matched by continuous complementary efforts to better understand how AI performs in the settings in which it is deployed.” Writing in a JAMA Special Communication, the authors
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Temporary Policies for Compounding Certain Parenteral Drug Products.” HHS has determined that public health emergencies now exist in the aftermath of hurricanes Helene and Milton based on reports from hospitals and health systems that they have experienced difficulties obtaining