Drugs
FDA has released a 5/15 proposed rule that, once finalized, would bring more transparency to the combination product regulatory process. The proposal is intended to streamline and clarify the appeals process for manufacturers, and align the regulations with more recent legislative and regulatory measures. “These regulations address the process
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval a new proposed information collection entitled “DSCSA Pilot Project Program,” under which the agency would establish the pilot as mandated by the Drug Supply Chain Security Act. It is intended to assist FDA in developing an interoperable, electronic system to identify
Drugs
Rep. Tulsi Gabbard (D-HI) and senator Bernie Sanders (I-VT) have introduced legislation to hold pharmaceutical companies accountable for profiting from America’s opioid epidemic. The Opioid Crisis Accountability Act of 2018 would fine drug companies for false marketing and distribution of opioids, and create criminal liability for top
Drugs
FDA has approved a subcutaneous formulation of Genentech’s Actemra (tocilizumab) for treating active polyarticular juvenile idiopathic arthritis in patients two years of age and older. FDA in 2013 approved an intravenous formulation of Actemra for patients two years of age and older for the same indication. Actemra can be
FDA Policy/General
FDA Panel To Review Cordis PMA Adverse Events Federal Register notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee reviews a Cordis PMA for the Incraft AAA Stent Graft System. 05/11/2018 Guide on Outsourcing Facility Definition Federal Register notice: FDA makes available a guidance
FDA Policy/General
Federal Register notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee is scheduled to meet 6/12 to review a Cordis PMA for the Incraft AAA Stent Graft System, which is intended for the endovascular treatment of infra-renal abdominal aortic aneurysms in patients with appropriate
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA has received questions from outsourcing facilities and other stakeholders
Drugs
President Trump’s just-released blueprint for lowering prescription drug prices orders FDA to require drug companies advertising their drugs to include pricing information in the advertisements. HHS secretary Alex Azar, who joined the president in a 5/11 Rose Garden announcement, had this to say: “Think about all the
Drugs
FDA has expanded the approval of Novartis’ Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. Gilenya was first approved by the FDA in 2010 to treat adults with relapsing MS. Approval was based on clinical trial data from 214 patients aged
Devices
Vyaire Medical has recalled its AirLife resuscitation devices and Broselow convenience kits due to risk of a malfunction caused by an error in the products’ design. The manual resuscitation devices are used together as one pair to provide constant ventilation to adults and children who are not breathing or cannot
Devices
A group of patient and industry organizations has written Congressional leaders urging them to enact legislation to “modernize the statutory oversight of clinical laboratory diagnostics, including laboratory developed tests (LDTs) and in vitro diagnostics (IVDs).” The 5/9 letter noted that FDA is currently reviewing an amended discussion draft of
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Request for Samples and Protocols” (OMB Control Number 0910–0206). FDA’s regulations give it authority to at any time require manufacturers of licensed biological products to submit samples of any lot along with the protocols showing
FDA Policy/General
Federal Register notice: FDA has determined that GE Healthcare’s sodium iodide I 123 oral solution, 2 millicuries/milliliter was not withdrawn from sale due to safety or effectiveness. The determination will allow FDA to approve ANDAs that cite this reference product. The FDA determination was made in response to
Drugs
FDA has posted a draft guidance on “Pediatric HIV Infection: Drug Development for Treatment” that provides general recommendations on developing drug products for such infections. The document is intended to help sponsors understand when it is appropriate to initiate pediatric formulation development and to begin pediatric studies to evaluate antiretroviral
Drugs
FDA has issued a guidance, Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act, to answer questions from outsourcing facilities and other stakeholders about the meaning of the term “outsourcing facility.” The document says questions have been received about whether multiple suites used for compounding human
Drugs
FDA and Oncolytics Biotech have reached agreement on a special protocol assessment for the protocol design, clinical endpoints, and statistical analysis approach for the company’s Phase 3 study evaluating Reolysin (pelarorep) for treating metastatic breast cancer. FDA granted Reolysin fast-track designation 5/2017 for treating metastatic breast cancer.
Drugs
FDA has filed two federal court complaints seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval due to significant GMP deviations. The actions were filed against U.S. Stem Cell Clinic (Sunrise, FL) and California Stem Cell Treatment Center (locations in Rancho
FDA Policy/General
Federal Register notice. FDA has made available a guidance entitled “S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling — Questions and Answers.” The International Council for Harmonization document provides additional information to facilitate interpretation of the guideline for industry “S3A Toxicokinetics:
Drugs
FDA has denied a Mylan 12/5/17 petition asking that the agency not approve any ANDA for a generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) that relies on multiple-batch pharmacokinetic bioequivalence study design unless, after conducting an appropriately rigorous review, the agency concludes that
Drugs
FDA has granted Sellas Life Sciences Group an orphan drug designation for its novel drug candidate, galinpepimut-S (GPS), for treating multiple myeloma. GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in several tumor types, according to the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.” The document is intended to assist sponsors in developing new drugs for such conditions. To view the notice, click here.
Drugs
FDA is asking drug developers to submit product applications (INDs, NDAs, BLAs, and ANDAs) with SNOMED CT nomenclature to state what disease or diseases the drug is indicated for. SNOMED CT is a nomenclature for the hundreds of thousands of clinical terms that characterize patient care that has been used