FDA Policy/General
Federal Register notice: FDA has announced a 9/10 Patient Engagement Advisory Committee meeting to discuss and make recommendations on “Cybersecurity in Medical Devices: Communication That Empowers Patients.” Recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients
Drugs
Under a 2017 CDER Manual of Policies and Procedures (MAPP), Prioritization of the Review of Original Abbreviated New Drug Applications (ANDAs), Amendments, and Supplements, ANDA submissions for drug products indicated for the emergency treatment of known or suspected opioid overdose are eligible for priority review. FDA says that based on
Drugs
A 7/6 New York Times editorial board opinion piece urges the Trump Administration to curb drug price increases the way Europe does – “by tying a drug’s price to its actual value.” It says HHS should evaluate and rank medications based on their cost effectiveness. The board notes that
Drugs
On the eve a rule was to go into effect requiring drug pricing information in direct-to-consumer ads, the Washington, DC federal district court ruled 7/8 that HHS lacks the statutory authority under the Social Security Act to mandate such disclosures. The 6/14 complaint from Merck, Eli
FDA Policy/General
Guide on Epidermolysis Bullosa Drug Development Federal Register notice: FDA makes available a final guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” 07/08/2019 Final Rule on CDRH Supervisory Review of Decisions Federal Register notice: FDA issues a final rule to amend its regulations on
FDA Policy/General
Sanofi and Google’s life sciences firm Verily say they will invest $500 million in a diabetes joint venture called Onduo that is intended to develop comprehensive solutions that combine devices, software, medicine, and professional care for disease management. The enterprise, which is based in Kendall Square in Cambridge, MA,
FDA Policy/General
DEVICES FDA has cleared an Integra LifeSciences Holdings 510(k) for its Integra Expandable Interbody System for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease. The device is intended for use with autogenous bone graft and supplemental fixation, and
Drugs
FDA has posted a final guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” The document focuses on drug development and trial design issues specific to the treatment of EB, including FDA’s current thinking on trial endpoints. The agency notes that there is not yet sufficient
FDA Policy/General
Federal Register notice: FDA has announced a 7/26 public workshop entitled “Endpoints for Drug Development in Heart Failure” which is intended to focus on endpoints related to symptoms and physical function. In addition, there will be discussion of the need to assess mortality effects of drugs under development for
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