Drugs
FDA has lifted a clinical hold on Alnylam Pharmaceuticals’ clinical studies with fitusiran, indicated for treating patients with hemophilia. Lifting the hold will allow trials to resume, including a Phase 2 open-label extension study and the ATLAS Phase 3 program, the company says. Alnylam company says it and the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “The Least Burdensome Provisions: Concept and Principles” that intends to eliminate unnecessary burdens that may delay product marketing. It describes the guiding principles and recommended approach for FDA staff and industry to encourage a consistent application of least burdensome
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Ultragenyx Pharmaceutical for obtaining approval of a rare pediatric disease product — Mepsevii (vestronidase alfa-vjbk), indicated for treating Mucopolysaccharidosis Type VII. To view the notice, click here.
FDA Policy/General
Federal Register correction notice: FDA is correcting an 11/27 notice entitled “Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop.” The date of the meeting has changed from 1/11/2018 to 3/8/2018. To view the notice, click here.
Drugs
The Project On Government Oversight (POGO) is questioning how biotech executive John F. Crowley, who president Trump profiled as an example of speeding drug development in a February address to Congress, was able to advance a stalled experimental drug called migalastat to a fast track review at FDA. Crowley’s
Devices
Medtronic has reached a $12 million settlement with five states to resolve allegations that it unlawfully promoted to doctors its Infuse bone graft device used in spinal fusion procedures. Oregon attorney general Ellen Rosenblum announced the settlement and said her state would receive $2.4 million. The other states participating
Devices
FDA has published a draft guidance, The Least Burdensome Provision: Concept and Principles, to describe the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles, as required by Congress in the FDA Modernization Act of 1997 for medical device premarket evaluation.
Biologics
Results of a study led by FDA scientists suggest that a new technology known as high throughput sequencing (HTS) could be standardized and used for rapid screening of biologic products, including vaccines, to demonstrate absence of contamination. The technology reportedly enables scientists to sequence hundreds of millions of DNA molecules
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Prescription Drug Marketing Act of 1987 — Administrative Procedures, Policies, and Requirements, OMB Control Number 0910-0435.” Reporting and recordkeeping requirements found in FDA regulations are intended to: (1) Ban the reimportation of prescription drugs produced in the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211) OMB Control Number 0910-0139.” The information collection requirements in GMP regulations provide FDA with the necessary information to perform its duty to
FDA Policy/General
Federal Register notice: FDA has announced a 3/19/18 public workshop entitled “Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” The workshop will discuss how interested parties might develop and submit proposed draft guidance on patient experience data for the agency’s
Drugs
Continuing the Amgen-Sandoz debate over provisions of the Biologics Price Competition and Innovation Act (BPCIA), the Federal Circuit Court of Appeals has ruled that state claims against Sandoz sought by Amgen are preempted by federal law. The appeals court heard the case on remand from the Supreme Court, which
Devices
An updated FDA assessment of the use of laparoscopic power morcellators (LPMs) to treat uterine fibroids says the agency continues to caution against their use in the majority of women undergoing myomectomy or hysterectomy to treat fibroids. “While minimally invasive surgery conveys several advantages over open surgery for women with
Drugs
FDA has just released the FDA-483 with five observations from a 1/7-1/23/14 inspection at Baxter Healthcare in Cleveland, OH. Specific observations on the form were: * the quality control unit lacks the responsibility and authority to reject all drug products; * control procedures are not established that
Devices
FDA has cleared a Chemence Medical 510(k) to market and sell Exofin Fusion, a new skin closure system for medium to large wounds. The device combines a self-adhering flexible mesh strip, mesh anchors and a 2-octyl cyanoacrylate topical adhesive to close and seal large incisions while forming
FDA Policy/General
As part of the HHS regulatory priorities for FY 2018, FDA will amend its regulations on the information patients receive for outpatient-administered prescription drugs. And to encourage more consumer-directed care, the agency plans to propose regulations to facilitate access to more treatments for common conditions by using new
Devices
FDA has cleared a Gel-e Inc. 510(k) for its adhesive bandage for prescription and over-the-counter use in managing moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision, the bandage may be used for managing pressure sores, diabetic ulcers, leg ulcers, donor sites and
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The submission is based on data from the Phase 3 CheckMate-214 study, which was stopped early based on the
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency’s 2018 policy goals include regulatory changes for drugs and medical devices. Writing in an FDA Voice online blog post, Gottlieb says the agency will issue several regulations on drug compounding to help ensure the quality of medicines that patients need. “We want
Drugs
FDA says it has created a Web site to provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. “This approach is intended to aid healthcare processionals in making more informed prescribing decisions that will both benefit their patients
Drugs
FDA has released the FDA-483 following an 11/20-11/30 inspection at Shilpa Medicare Limited, a sterile and non-sterile drug manufacturer in Telangana, India. Inspection observations shown on the form were: * redacted * scientific rationale could not be provided for some commercial product specifications; * procedures for the cleaning
Drugs
FDA has published a guidance, Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs, with recommendations on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial and antifungal drugs as established by the 21st Century Cures Act. Included are the agency’