FDA Policy/General
Federal Register notice: FDA has announced a 9/13 public workshop entitled “Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices” to discuss potential scientific and regulatory challenges associated with developing traditional antimicrobial susceptibility testing (AST) devices and devices that detect antimicrobial resistance markers by molecular or novel diagnostic technologies,
FDA Policy/General
Federal Register notice: FDA is seeking comments on a statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original BLAs. The program is part of agency performance commitments under the proposed reauthorization of the Biosimilar User Fee Act. As part of these commitments,
FDA Policy/General
Researchers at the Oregon Health & Science University and Memorial Sloan Kettering Cancer Center say there are questions raised by Incyte’s partnership with the television soap opera General Hospital over a story line involving a character diagnosed with polycythemia vera (PV) and a blood clot. Writing in the Journal
FDA Policy/General
The House Appropriations Subcommittee on Agriculture/FDA has advanced to the full committee an FDA funding bill that provides almost $2.8 billion ($4.473 billion when excluding tobacco user fees) in direct budget authority for fiscal year 2018, which is the same level as FY 2017. In his opening
FDA Policy/General
Former FDA commissioner Robert Califf says he returned to Duke University to be part of “an infectious excitement surrounding the topic of health data science and what it can do for health and healthcare.” Writing in an online blog post, Califf says the university has created a campus-wide center
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Reports of Corrections and Removals — 21 CFR Part 806 OMB Control Number 0910–0359.” Under 21 CFR 806.10, device makers must report to FDA within 10 working days any action to correct or remove
FDA Policy/General
An 11/7-11/10/16 FDA inspection at Pulmonary and Sleep Center of the Valley, McAllen, TX, conducted as part of the Bioresearch Monitoring Program, determined that the center did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Extralabel Drug Use in Animals — 21 CFR Part 530 OMB Control Number 0910–0325.” The regulation permits FDA, if it finds that there is a reasonable probability that the extralabel use of an animal drug may present
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Biomarin for gaining approval of a rare pediatric disease product application for Brineura (cerliponase alfa) that met certain agency criteria. FDA is required to publish notice of the award of the priority review voucher. Brineura is indicated to slow
FDA Policy/General
The House Appropriations Committee has released a draft bill covering FDA’s fiscal year 2018 budget that dismisses the Trump Administration’s request to double industry-funded user fees. Under the draft, the agency would receive a total of $2.8 billion in discretionary funding, which is equal to the
FDA Policy/General
Attorneys Bert Rein and Megan Brown (Wiley Rein) say that government legislators and regulators should “think long and hard before using any speech restraint or compelled disclosure to pursue their consumption preferences or policy goals.” Writing in a Washington Legal Foundation Legal Opinion Letter, the two say that while the
FDA Policy/General
Federal Register notice: FDA is asking for comments on an information collection extension for “Annual Reporting for Custom Device Exemption OMB Control Number 0910– 0767.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced an 8/2 Arthritis Advisory Committee meeting to discuss a Janssen Biotech BLA for Plivensia (sirukumab injection). The submission is seeking approval for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one
FDA Policy/General
Public Meeting Planned on Alopecia Drug Development Federal Register notice: FDA announces a 9/11 public meeting on “Patient-Focused Drug Development for Alopecia Areata.” 06/23/2017 Nominations Sought for Device GMP Panel Members Federal Register notice: CDRH seeks nominations for voting members to serve on the Device Good
FDA Policy/General
Federal Register notice: FDA is seeking comments on a submission involving proposed recommendations for industry on developing continuous manufacturing for solid dosage drug products. The Center for Structured Organic Particulate Systems (C-SOPS) recently submitted an industry-coordinated best practices document on continuous manufacturing. FDA is interested in public comments
FDA Policy/General
Federal Register notice: FDA has announced a 9/11 public meeting on “Patient-Focused Drug Development for Alopecia Areata.” The meeting will allow the agency to obtain patients’ perspectives on the impact of alopecia areata, including on daily life. It is also seeking patients’ views on treatment approaches and decision
FDA Policy/General
Federal Register notice: CDRH is seeking nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee. Nominations received on or before 8/22 will be given first consideration for membership on the panels. To view the notice,
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 121 NDAs and 161 ANDAs from multiple applicants. The application holders notified the agency that the drug products were no longer marketed and requested that the approvals be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 7/18 public meeting on “‘The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The meeting is seeking comments on the administration of the Hatch-Waxman Amendments to help ensure the intended balance between encouraging innovation in drug development and accelerating
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Application for Participation in FDA Fellowship Programs.” The collection involves brief online applications completed by applicants applying to FDA’s fellowship programs. They allow the agency to efficiently review information from students and healthcare professionals who are
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “FDA Rapid Response Surveys (Generic Collection) OMB Control Number 0910–0500.” The notice covers rapid response surveys for community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology
FDA Policy/General
Federal Register notice: FDA has announced a 7/19 public workshop on scientific and clinical trial design considerations for developing new tuberculosis (TB) treatment regimens. Workshop discussions will focus on drug development programs and studies intended to evaluate shorter and better tolerated TB drug regimens and new regimens that have