Drugs
Pending right-to-try legislation in Congress, which would give terminally ill patients access to investigational drugs, is an ill-advised political stance that would “circumvent” FDA’s authority and offer patients false hope, according to an online post from Friends of Cancer Research chair and founder Ellen V. Sigal.
FDA Policy/General
Draft Guide on Product Tracing Standardized Data Federal Register notice: FDA makes available a draft guidance on “Standardization of Data and Documentation Practices for Product Tracing.” 03/02/2018 Guide on Genomic Sampling and Managing Data Federal Register notice: FDA makes available a guidance entitled “E18 Genomic Sampling and Management
Devices
FDA has given 510(k) clearance to the Cardiovascular Systems’ OrbusNeich 1.0mm Sapphire II Pro coronary balloon. The company says it is the first and only 1.0mm coronary balloon available in the U.S.
Devices
A CDRH and CBER proposal on Voluntary Malfunction Summary Reporting Program for manufacturer reporting of certain device malfunction medical device reports (MDRs) has gained the backing of device industry trade group AdvaMed and drawn criticism from women’s health advocates. The proposed program is intended to streamline malfunction reporting and
Drugs
FDA has issued a safety alert about unapproved products claiming to prevent, treat or cure influenza. “As the flu continues to make people sick — and even cause deaths — unscrupulous actors may also be taking advantage of unsuspecting consumers by promoting their fraudulent products that have not been reviewed by the
Drugs
Biogen and AbbVie have announced the worldwide withdrawal of Zinbryta (daclizumab)for relapsing multiple sclerosis (MS) due to safety concerns, including reports of severe liver damage and immune-related conditions. The companies said that “characterizing the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward
Drugs
President Donald Trump wants the federal government to bring lawsuits against pharmaceutical companies that may have used false, deceptive or unfair marketing practices to help fuel the U.S opioid abuse crisis. Speaking at a 3/1 White House summit on opioid addiction, Trump said he raised the issue with
Devices
FDA has cleared an Alfa Scientific Designs 510(k) for its Simple Cup multi-drug test with Driven Flow, a multi-drug of abuse urine test. The urine immunoassay identifies 13 drugs or drug metabolites and it yields results in two minutes while maintaining line integrity for at least two
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Standardization of Data and Documentation Practices for Product Tracing.” The document discusses the standards for the interoperable exchange of transaction information, transaction history, and transaction statements (product tracing information) provided under the drug supply chain security provisions of the
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “E18 Genomic Sampling and Management of Genomic Data.” The International Council for Harmonization guidance focuses on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data in clinical studies. It is intended to provide harmonized
Drugs
FDA has accepted for review a Jazz Pharmaceuticals NDA for solriamfetol, an investigational drug for treating excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. The agency has set a user fee review action target date of 12/20. The submission includes data from a Phase 3 clinical
FDA Policy/General
Federal Register notice: FDA has announced a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting is scheduled to provide information and solicit input on current
Drugs
Attorneys David Gibbons and Dara Levy (Hyman, Phelps and McNamara) say that FDA interpretations of regulations on importation of active pharmaceutical ingredients (API) are driving manufacturing of investigational finished drug products outside the U.S. In a post in their firm’s FDA Law Blog, the two write that under
Drugs
FDA has posted an International Council for Harmonization guidance “E18 Genomic Sampling and Management of Genomic Data.” The document is intended to provide harmonized principles for genomic sampling and managing genomic data in clinical studies. It also is structured to facilitate the implementation of genomic studies by enabling a common
Drugs
FDA has selected Booz Allen Hamilton for one of two spots on a competitive $300 million seven-year blanket purchase agreement to support implementation of a CDER transformational informatics platform to enable the Center to bring drugs to market with greater speed and efficiency. The company says its team of
Biologics
CBER researchers say they have demonstrated unexpected changes in the shape and size of multipotent stromal cells (MSCs) when preparations of the cells interact with specific engineered culture systems. An FDA news release says the finding is a step toward understanding how to accurately interpret studies that use such systems,
FDA Policy/General
Federal Register notice: FDA has reopened a docket for public comment on the susceptibility test interpretive criteria for antibacterial and antifungal drugs provided by FDA on its Susceptibility Test Interpretive Criteria Web page established 12/13/2017. On this page, FDA recognizes susceptibility test interpretive criteria standards established by standard
Drugs
FDA has accepted for review a Pain Therapeutics NDA resubmission for Remoxy ER (oxycodone capsules), indicated for treating severe pain. The agency has set a user fee review action target date of 8/7. The drug has a long history at FDA, having been rejected on three previous submissions. The
Drugs
FDA has extended the PDUFA review target date for Allergan’s ulipristal acetate to 8/2018 to allow time for a full file review. The company says ulipristal is an investigational drug for treating abnormal uterine bleeding in women with uterine fibroids. It is described as a progesterone receptor modulator
Drugs
FDA has confirmed the capability of four additional European Union (EU) countries to conduct good manufacturing practice (GMP) drug inspections under the mutual recognition agreement between FDA and the EU. The addition of Czech Republic, Greece, Hungary, and Romania brings to 12 the list of EU member states whose results
Drugs
Mylan and Revance Therapeutics have entered into a collaboration to develop a proposed biosimilar to Botox (onabotulinumtoxinA). The collaboration includes a $25 million upfront payment to Revance, with contingent milestone payments upon achievement of additional clinical, regulatory and sales targets. Botox is indicated for treating bladder conditions, migraine headaches, muscle
Drugs
A new FDA safety alert warns health care professionals and patients not to use compounded drug products made by Cantrell Drug Co. (Little Rock, AR) due to quality issues. An agency notice says the alert covers opioid products and other drugs intended for sterile injection. “The agency is concerned about