Drugs
The 3rd Circuit Court of Appeals has remanded to a Pennsylvania federal court a Federal Trade Commission (FTC) case charging that the owners of the AndroGel patent—AbbVie, Abbott, Unimed Pharmaceuticals, and Besins Healthcare—filed sham patent infringement suits against Teva and Perrigo and that AbbVie, Abbott, and Unimed entered
Drugs
Reports published by Democratic members of the House Oversight Committee say that enormous drug company profits are the primary driver of increasing prescription drug prices in the U.S. Kaiser Health News says that the first two reports look at Celgene and Bristol-Myers Squibb’s Revlimid (lenalidomide) cancer treatment
Drugs
The Massachusetts federal court allowed misdemeanor convictions to stand in an off-label promotion case but said “it seems clear that the statutory and regulatory scheme needs to be re-thought.” Attorney Stephen McConnell (Reed Smith) writes online in a Drug and Device Law Blog post that the judge pointed
Drugs
FDA has lifted a clinical hold against Solid Biosciences’ IGNITE DMD Phase 1/2 clinical trial involving SGT-001, a novel adeno-associated viral vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne muscular dystrophy. The hold was originally placed 11/2019 after the company
Drugs
A review of FDA inspection documents on the agency’s clinical trial oversight during the past 11 years shows enforcement is often light-handed, slow-moving, and secretive, according to the journal Science. The review period of documents obtained under the Freedom of Information Act covered former president Obama’s
FDA Policy/General
Writing in a Washington Post op-ed, seven former FDA commissioners warn that the perception of political influence in FDA’s science-based decisions matters and say “political intrusion only prolongs the pandemic and erodes our public health institutions.” The op-ed was signed by Robert Califf, Scott Gottlieb, Margaret
Devices
FDA says it has updated the SARS-CoV-2 reference panel comparative data on the agency Web site to reflect the latest information. The panel is described as an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes. The agency
Drugs
FDA has published a draft guidance, The Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls, with general recommendations for the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications employed by IND sponsors and applicants for NDAs,
Drugs
Catalyst Pharmaceuticals says it will appeal to the 11th Circuit Court of Appeals a ruling by a Florida federal court granting summary judgment to FDA and Jacobus Pharmaceutical and dismissing Catalyst’s case involving orphan drug exclusivity for its Firdapse (amifampridine). In its decision, the district court accepted the report
FDA Policy/General
Federal Register notice: FDA has announced an amendment to a 10/22 Vaccines and Related Biological Products Advisory Committee meeting. The “address” portion of the earlier document is changed to read as follows: “The online Web conference meeting will be available at the following link: http://fda.yorkcast.com/webcast/
FDA Policy/General
Federal Register notice: FDA has announced a 10/6 public meeting entitled “Patient-Focused Drug Development for Stimulant Use Disorder” that was originally scheduled to occur 3/10. The purpose is to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use
Drugs
FDA says it has launched its newly redesigned Sentinel Initiative Web site. The agency says the new Web site was designed to increase organization and usability and to assist the Sentinel community with up-to-date information on Sentinel assessments, tools, and news.
Devices
FDA says its ongoing evaluation of the risk of Nontuberculosis mycobacteria (NTM) infections in patients who undergo cardiothoracic surgery using heater-cooler devices has found three U.S. patients from one facility who were infected with Mycobacterium abcessus (a type of NTM) after undergoing cardiothoracic surgery involving the use of
Biologics
Despite statements from president Trump that a new guidance from FDA on stricter requirements for Covid-19 vaccine makers will need to be approved by the White House, CBER director Peter Marks said 9/29 that vaccine makers already know the guidance’s recommendations about what data are necessary to
Drugs
The Covid-19 pandemic has led to a further deterioration in the U.S. clinical trials system, CDER director Janet Woodcock acknowledged 9/29 during a Friends of Cancer Research program. Woodcock, who is currently on detail to Operation Warp Speed, said that once the pandemic emergency is over, the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk — Questions and Answers. The document provides a practical approach that is applicable to the identification, categorization, qualification, and control of mutagenic impurities to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. The document is intended to assist applicants in responding to ANDA complete response letters. In addition, this guidance recommends information an applicant may submit in its
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Breast Implants — Certain Labeling Recommendations to Improve Patient Communication. The document contains recommendations on the content and format for certain labeling information for saline and silicone gel-filled breast implants. To view the notice, click here.
Drugs
FDA has published a draft guidance, E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential—Questions and Answers. The document contains revisions to sections 5.1 and 6.1 of the current questions and answers for the International Council for Harmonization’s ICH E14
Drugs
FDA says the GDUFA science and research program has awarded a five-year, $5 million grant to the Universities of Maryland and Michigan to establish a Center for Research on Complex Generics. An announcement says the center “aims to enhance research collaborations with the generic industry to further FDA’s
Drugs
The HHS Office of Inspector General (OIG) says FDA has struggled the measure the effectiveness of the REMS (Risk Evaluation and Mitigation Strategies) for transmucosal immediate-release fentanyl (TIRF) drugs and extended-release/long-acting (ER/LA) opioids in mitigating the misuse of opioids. An OIG report says that while
FDA Policy/General
Former FDA principal deputy commissioner Joshua Sharfstein and two other researchers say “FDA should look to increase transparency and maximize public trust in its integrity.” Writing in a Stat online opinion column, the three offer four ways in which the agency could increase transparency. They start their column by discussing