FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Humanitarian Device Exemption (HDE) Program.” The document explains the criteria FDA considers to determine if “probable benefit” has been demonstrated as part of the Agency’s decision-making process regarding marketing authorization for a humanitarian use device. The guidance
FDA Policy/General
Federal Register notice: FDA has announced that it accepted a priority review voucher to approve AbbVie’s Rinvoq (upadacitnib) on 8/16. The once-daily oral Janus kinase inhibitor is indicated for treating adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to
FDA Policy/General
Review Period Determined for Giapreza Federal Register notice: FDA determines the regulatory review period for La Jolla Pharmaceutical’s Giapreza (angiotensin II). 09/06/2019 Guide on Pediatric Partial Onset Seizures Federal Register notice: FDA makes available a final guidance entitled “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation
FDA Policy/General
DEVICES Accuray Inc. has received FDA 510(k) clearance for its Radixact Treatment Delivery Platform and its new treatment planning and data management systems, Accuray Precision Treatment Planning System and iDMS Data Management System. The company says these next generation hardware and software solutions make up the new Radixact system,
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for La Jolla Pharmaceutical’s Giapreza (angiotensin II), a vasoconstrictor for increasing blood pressure in adults with septic or other distributive shock. The review period is 1,639 days, which includes 1,463 days that occurred
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients Two Years of Age and Older.” The document addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Guidance for Industry on E6 (R2) Good Clinical Practice; International Council for Harmonization; Integrated Addendum to ICH E6 (R1).” The guidance is intended to facilitate implementation of improved and more efficient approaches to clinical trial design, including
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Applications for Food and Drug Administration Approval To Market a New Drug: Patent Submission and Listing Requirements” (OMB Control Number 0910-0513). FDA requires all NDA applicants to file, as part of an NDA, the patent number
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound drug products to add five additional bulk drug substances to the list. The proposed rule also identifies 26 bulk drug substances that FDA has considered and
FDA Policy/General
Based on information from sources familiar with the process, BioCentury is reporting that HHS secretary Alex Azar has sent to the White House the names of three individuals as potential FDA commissioner. The online report identifies them as: * Acting commissioner Ned Sharpless; * University of Texas M.D. Anderson Cancer Center
FDA Policy/General
Former CDER associate director for genomics (2004-2008) Felix Frueh has joined NDA Partners as an expert consultant. At FDA, he led the agency’s first genetic and genomic review division and established the biomarker qualification process and companion diagnostic development policies. In his new role, Frueh will use his
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Current Good Manufacturing Practice (CGMP) for Positron Emission Tomography (PET) Drugs” (OMB Control Number 0910-0667). The CGMP requirements require written procedures as well as recordkeeping related to ongoing manufacturing of individual PET drugs, testing, and product
FDA Policy/General
Representatives of 57 healthcare advocacy organizations and four former FDA commissioners have written to President Donald Trump and HHS secretary Alex Azar urging that they nominate FDA acting commissioner Ned Sharpless to become the permanent commissioner. Under federal regulations, Sharpless can only serve as acting commissioner until early November, the
FDA Policy/General
Federal Register notice: FDA has announced an 11/6-7 General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee meeting. On both days, panel members will discuss industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Abbreviated New Animal Drug Applications — Section 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). To view
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” The document discusses uncertainty as part of the agency's overarching approach to a benefit-risk based framework
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Millennium Pharmaceuticals’ Bevyxxa (betrixaban maleate), indicated for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility
FDA Policy/General
Turing Pharmaceuticals says it has begun dosing the first group of subjects in a single ascending dose study, to evaluate the safety, tolerability and pharmacokinetics of an oral formulation of TUR-004 in healthy young adult subjects. The company says the study is aimed at obtaining approval for treating epileptic
FDA Policy/General
BIOLOGICS FDA has approved Sandoz’s Zarxio (filgrastim-sndz), a copy of Amgen’s Neupogen (filgrastim), indicated for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee panels. Nominations should be made before 10/29 to be giveen first consideration for membership on the panels. There are 48 current or
FDA Policy/General
Federal Register notice: FDA has corrected the docket number in a 12/2017 notice entitled “Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance.” Docket number “FDA-2017-N-6476” has been corrected to read “FDA-2017-D-2991.” To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on nine bulk drug substances that the agency has considered and is proposing not to include on its list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding. The nine bulk drug substances are: dipyridamole, ephedrine