Drugs
New research published in the 10/25 online PLOS One journal and supported by CDRH’s Division of Biostatistics outlines an approach that could lead to more patient-reported outcome measures (PROM) being included in drug and device labeling. The researchers say the “PROM has to be valid, reliable and
FDA Policy/General
Info Collection Extension for REMS Requirements Federal Register notice: FDA seeks comments on an information collection extension entitled “Prescription Drug Product Labeling; Medication Guide Requirements.” 10/26/2018 Comment Period Reopened on Sucralfate Guide Federal Register notice: FDA reopens the comment period for a revised draft product-specific guidance on
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a revised draft product-specific guidance on sucralfate that appeared in a 10/20/2017 notice. The reopening is in response to two citizen petitions and the agency has determined that the petitioners and other stakeholders can submit comments by
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Biopharmaceutics Classification System-Based Biowaivers” that was prepared by the International Council for Harmonization. The document provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of in vivo bioequivalence studies for
Drugs
Shire has filed a submission seeking FDA approval for a new plasma manufacturing operation near Covington, GA to manufacture Flexbumin 25% [albumin (human)], which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions. Shire received FDA approval for the Georgia facility to manufacture
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Eli Lilly’s Taltz (ixekizumab), indicated for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The regulatory review period was determined to be 3,036 days,
Drugs
FDA has accepted for priority review a Taiho Oncology supplemental NDA for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction. The agency has set a user fee review action target of 2/24/2019.
Drugs
An FDA Advisory Committee has delivered a mixed vote (10 to 9) in favor of continuing required cardiovascular outcomes trials for all new diabetes drugs. In delivering the mixed vote, the majority of panel members recommended that modifications are necessary to the requirements for conducting such trials, for example allowing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Prescription Drug Product Labeling; Medication Guide Requirements” (OMB Control Number 0910-0393). To view the notice, click here.
Drugs
Faced with resistance from the pharmaceutical industry, Health and Human Services Secretary and former Eli Lilly executive Alex Azar said 10/26 that HHS is steadfast with the Trump Administration’s plans to change the way Medicare pays for costly physician-administered drugs. Currently, these drugs are reimbursed at the
Drugs
Attorneys Deborah Livornese, JP Ellison, and Josephine Torrente (Hyman, Phelps & McNamara) say CDER should change its current process and provide access to complete agency drug reviews to sponsors who are issued a complete response letter (CRL) advising them of the reasons the agency cannot approve an application in its
Drugs
FDA has issued a draft International Conference for Harmonization guidance, M9 Biopharmaceutics Classification System-Based Biowaivers, with recommendations to support the biopharmaceutics classification of drug substances and the BCS (biopharmaceutics classification system)-based biowaiver of bioequivalence studies for drug products. The document says biowaivers may be used to demonstrate bioequivalence,
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Testicular Toxicity: Evaluation During Drug Development.” The document addresses nonclinical findings that may raise concerns of a drug-related adverse effect on the testes, clinical monitoring of adverse testicular effects early in clinical development, and the design and conduct of
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document covers the statutory verification system requirements that include quarantine and investigation of a product determined to be suspect, and quarantine and disposition of a
Drugs
FDA commissioner Scott Gottlieb says the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, recently signed by the President, gives FDA new authorities “that we believe will meaningfully advance our efforts, and the agency will take immediate steps to implement this legislation
Devices
CDRH has posted information on its Accreditation Scheme for Conformity Assessment (ASCA), an expansion of the Center’s standards program to include a pilot accreditation initiative to improve the device review process. The post says ASCA allows FDA to work directly with accreditation bodies that will accredit testing laboratories to
Devices
FDA has issued a revised safety alert on Alcon’s CyPass Micro-Stent, a small tube with tiny holes that is surgically implanted in the eye, due to its risk of eye damage. The device is used to drain fluid that causes high eye pressure and vision loss in people
Drugs
FDA has cleared a Masimo 510(k) for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry that is intended to provide improved SpO2 (peripheral capillary oxygen saturation) accuracy specifications for all patients greater than 3 kg. RD SET single-patient-use sensors with
FDA Policy/General
Federal Register notice: FDA has awarded a priority review voucher to Leadiant Bioscience after determining that rare disease drug Revcovi (elapegademase-lvlr) injection meets the award criteria. The product is approved for treating adenosine deaminase-severe combined immunodeficiency in pediatric and adult patients. To view the notice, click here.
Drugs
A White House Council of Economic Advisors report praises efforts by HHS and FDA to respond to the problem of high drug costs. “FDA regulations intended to guarantee safety and efficacy can constitute barriers to price competition for drugs,” the report says. “In few other industries do firms spend over
Drugs
FDA has published a draft guidance, Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs, to give the agency’s of the law’s requirements for verification systems. The document includes recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products,
Drugs
FDA has approved an updated label for Novo Nordisk’s weight management drug Saxenda (liraglutide) injection 3 mg to add data from the LEADER trial showing that liraglutide 1.8 mg in another product did not increase the risk of major cardiovascular (CV) events in adults with Type 2 diabetes