Drugs
FDA has released a draft guidance entitled “Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC).” The document discusses clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions. FDA says that selecting
Drugs
FDA Oncology Center of Excellence director Richard Pazdur has taken the unusual step of calling into question the development of dozens of oncology drug development programs that rely almost exclusively on clinical data from China. Writing in a 2/4 The Lancet comment piece, Pazdur and oncology divsion director Harpreet
Drugs
A just-released Government Accountability Office report has offered recommendations on an FDA planned pilot program to test unannounced foreign inspections. The pilot will look at bringing foreign inspections on equal footing with domestic inspections, which traditionally have been unannounced. The agency is also looking at eliminating the option of
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 1/11 notice about a draft guidance entitled “Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act.” Comments should now
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” To view the notice, click here.
FDA Policy/General
Comments Extended on Device Modeling/Simulation Guide 2/4/2022 Federal Register notice: FDA is extending the comment period for a 12/23 notice on a draft guidance entitled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” Comments should now be submitted by 3/4. To
FDA Policy/General
Contract research organization Chiltern International has hired investment firm Jefferies to investigate a potential sale valued around $1.3 billion. Chiltern focuses on early phase and global development in oncology, dermatology, neuroscience, endocrine and metabolic, ophthalmology, gastroenterology and respiratory areas. The company has more than 4,300 sites across 47
FDA Policy/General
DEVICES Cerapedics has received FDA approval of its PMA for i-FACTOR Peptide Enhanced Bone Graft for use in anterior cervical discectomy and fusion procedures in patients with degenerative cervical disc disease. FDA has cleared a Convergent Dental 510(k) for Solea, a CO2 9.3 micron dental laser for
Devices
FDA has issued a warning to not use the E25Bio Covid-19 Direct Antigen Rapid Test (DART). “This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by
Drugs
FDA says it is lifting its domestic inspection pause and will resume conducting inspections in the U.S beginning 2/7 across all commodities now that Covid-19 cases are dramatically declining. “In addition to the resumption of planning and conducting domestic surveillance inspections on 2/7, the FDA continues
Drugs
FDA has issued Wells Pharma (Houston, TX) a one-item Form FDA-483 after a 6/2021 inspection at the drug outsourcing facility. The inspection cited the firm’s procedures designed to prevent microbiological contamination of sterile drug products because they are not established, written and followed, according to the
Drugs
FDA has posted a final guidance entitled “Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the Covid-19 Pandemic.” The document is intended to help sponsors mitigate the challenges related to the constrained supply of nonhuman primates available for conducting nonclinical toxicity assessments. It is intended to remain
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format.” The document provides recommendations for incorporating clinically relevant immunogenicity information into the labeling of products having immunogenicity assessments. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Population Pharmacokinetics.” The document is intended to assist sponsors in applying population pharmacokinetics during the drug development process to inform drug use. It also includes FDA’s current thinking on the data and model requirements for population PK analyses
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Assessment of Pressor Effects of Drugs.” The document is intended to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is classifying the photoplethysmograph analysis software for over-the-counter use into medical device Class 2 (special controls). The action responds to an Apple Inc. de novo classification request for its Irregular Rhythm Notification Feature. The agency says the device has been identified as analyzing photoplethysmograph
Drugs
FDA has accepted for review a Cytokinetics NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator for treating heart failure with reduced ejection fraction (HFrEF). The agency set a user fee review action target date of 11/30. The submission is based on data from the 8,
Drugs
FDA commissioner nominee Robert Califf is promising, if confirmed by the Senate, to crack down on drug companies that gain accelerated approval and then fail to adequately pursue confirmatory evidence as required by the agency in postmarketing commitments. In a bid to gain the backing of Senator Ron Wyden (D-
Drugs
Reps. Anna Eshoo (D-CA), Brian Fitzpatrick (R-PA), and Robin Kelly (D-IL) have introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. They say (includes a link to the bill text) the measure is intended to boost diversity in clinical trials by requiring enhanced data reporting
Drugs
Pfizer and Ionis Pharmaceuticals are discontinuing the Pfizer-led clinical development program for vupanorsen, an investigational antisense therapy that was being evaluated for potential indications in cardiovascular risk reduction and severe hypertriglyceridemia. An announcement says Pfizer decided after a thorough review of data from a global Phase 2b study of
Drugs
The FDA Office of Clinical Pharmacology (OCP) has issued its 2021 annual report that highlights its efforts to “improve public health by building and translating knowledge of drug-response into patient-centered regulatory decisions of the highest quality.” The report says that in 2021 OCP addressed multiple public health issues,
Drugs
FDA says it is investigating a possible increased risk of death with TG Therapeutics’ Ukoniq (umbralisib), approved to treat two specific lymphomas. An agency drug safety communication says FDA has determined that initial findings from a clinical trial evaluating Ukoniq to treat a related type of cancer found a possible