FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Treatment for Heart Failure: Endpoints for Drug Development.” The document clarifies that an effect on symptoms or physical function, without a favorable effect on survival or hospitalization, can be a basis for approving drugs to treat heart failure. It
FDA Policy/General
Federal Register proposed rule: FDA has proposed to amend its regulations concerning the use of master files for biological products. If finalized, the rule would allow certain biological products to continue to incorporate by reference information about drug substances, drug substance intermediates, or drug products contained in master files. The
Drugs
FDA has approved Janssen Pharmaceutical Companies’ Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Approval was based on data from the Phase 3 MAIA (MMY3008) clinical study, which showed that the combination significantly reduced
Biologics
FDA has approved a Pfizer BLA for Zirabev (bevacizumab-bvzr), a biosimilar to Genentech’s Avastin (bevacizumab), indicated for treating five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or
FDA Policy/General
The House has passed FDA’s fiscal year 2020 budget as part of HR 3055, a five-bill minibus that covers spending for Agriculture-FDA, Commerce-Justice-Science, Interior-Environment, Military Construction-VA, and Transportation-HUD. Under the measure, FDA would receive a $185 million (6%) increase for FY 20,
FDA Policy/General
Pfizer says former FDA commissioner Scott Gottlieb has been elected to its board of directors. Gottlieb was also appointed to the board’s regulatory and compliance committee and the science and technology committee. Gottlieb, who left FDA two months ago, is currently a special partner at New Enterprise Association’s
FDA Policy/General
In observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of Dickinson's FDA Webview are closed until Monday, July 8. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Rep. Frank Pallone (D-NJ), chairman of the House Energy and Commerce Committee, is asking FDA for an update on its inspections of imported cosmetics products. In a 6/26 letter to FDA acting commissioner Ned Sharpless,Pallone says he is concerned that less than 1% of cosmetic products that
Drugs
FDA is proposing a new rule that would enable the seamless transition of some biologics approved under the Federal Food, Drug, and Cosmetic Act (FFDCA) to licensed biologics under the Public Health Service Act. The proposed rule would amend agency regulations on the use of drug master files to allow
Drugs
FDA has published an International Council on Harmonization guidance, M10 Bioanalytical Method Validation, with recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples. “Adherence to the principles presented in this guideline will improve the quality and consistency
Drugs
FDA has posted two videos discussing the Complex Innovative Trial Design pilot meeting program to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The videos introduce the program and discuss its process. The post says the pilot is designed
Drugs
FDA has published a draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, giving the agency’s current thinking about developing drugs to treat heart failure and highlighting remaining areas of uncertainty to encourage discussion and alternative approaches. The document’s purposes are to (1) make it clear that
FDA Policy/General
Federal Register notice: FDA has made available a draft guide entitled “E19 Optimization of Safety Data Collection.” The document provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or post-marketing studies of drugs where the safety profile is well understood
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.” The document provides detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, and includes guidance describing the types of modifications to a diagnostic ultrasound device for which
FDA Policy/General
Federal Register notice: FDA is seeking public comment on its Clinical Data Summary Report Pilot program as part of the agency’s continuous assessment of the efficiency and transparency of the clinical data used in regulatory decision making. The Agency is also seeking public feedback on a new integrated review
Devices
An online Kaiser Health News post lists five key items the service found in its review of a recently published FDA “alternative summary” database often used by medical device manufacturers to report injuries or malfunctions, bypassing the public MAUDE database used by doctors, researchers, and patients. The news service says
Devices
FDA says 11 Medtronic MiniMed and MiniMed Paradigm insulin pumps have potential cybersecurity risks and diabetes patients using the specific models should switch their insulin pump to models that are better equipped to protect against the potential risks. An FDA safety communication lists the 11 affected models and offers recommendations
Drugs
Under a contract with CDER, EdjAnalytics, a data science firm providing artificial intelligence, machine learning and advanced analytics for life sciences, has developed a predictive model to support the agency’s decision-making process to select manufacturing sites for inspection. “The model provides the likelihood of a facility having an
Devices
Vyaire Medical has recalled its enFlow Fluid Warming System disposable cartridges due to the potential for aluminum to elute from the warmer into the fluids, which could expose patients to unsafe levels of aluminum. “Exposure to unsafe levels of aluminum may result in serious adverse health consequences including, but not
Drugs
Durect has submitted a detailed reply to an FDA 2014 complete response letter for Posimir (bupivacaine extended-release solution), a post-operative pain relief depot product that uses the company’s Saber technology. The product is designed to be administered directly into a surgical site to deliver bupivacaine for up
Drugs
Members of the congressional Problem Solvers Caucus, 23 Democrats and 23 Republicans from both the House and the Senate, have released a list of seven principles for supporting prescription drug pricing legislation. A media statement from Sens. Susan Collins (R-ME) and Joe Manchin (D-WV) said legislation to address
FDA Policy/General
FDA is proposing research into disease awareness and prescription drug communications on television. A Federal Register notice says that when drug companies market a new drug, they often also release disease awareness communications about the medical condition the drug is intended to treat. The CDER Office of Prescription Drug Promotion