Devices
FDA has cleared a Hologic 510(k) for its Group B Streptococcus (GBS) assay on the Panther Fusion system. The company says clinical research has showed that the assay exhibited 100% sensitivity compared to culture-based testing methods. “The assay will also increase testing options for healthcare providers, as it
Biologics
Evolus has resubmitted a BLA for DWP-450 (prabotulinumtoxinA) for treating glabellar lines, also known as frown lines, in adult patients. If approved, DWP-450 would be a competitor to Allergan’s Botox. The resubmission follows a May complete response letter that requested the submission of additional data to complete
Drugs
Members of the FDA Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products advisory committees will be asked 8/3 to review data from the most recent assessment of the REMS (Risk Evaluation and Mitigation Strategy) with Elements to Assure Safe Use for transmucosal immediate-
Drugs
Attorney Michelle Yeary (Dechert) says a Florida federal court rendered a mixed decision in a failure-to-warn case against Novartis involving a drug used to treat leukemia. Writing in a Drug & Device Law blog post, Yeary says the court didn’t agree that the suit was preempted by
Drugs
FDA says it has awarded nearly $6 million in grants to three research institutions to study how cutting-edge manufacturing technologies can be implemented in a way that leads to more innovative, consistent, and dependable manufacturing of drug and biological products. Grant recipients were Rutgers University, Massachusetts Institute of Technology,
FDA Policy/General
Federal Register notice: FDA has announced the fiscal year 2019 for prescription drug user fees. These include an application requiring clinical data ($2,588,478), an application not requiring clinical data ($1,294,239), and the prescription drug program fee ($309,915). These fees are effective 10/1. To view
FDA Policy/General
Federal Register notice: FDA has announced the fiscal year 2019 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities — the FY 2019 small business establishment fee ($5,461), the non-small business establishment fee ($18,375), and
Drugs
AuroMedics Pharma has recalled two lots of piperacillin and tazobactam for injection, USP 3.375 g due to concerns that vials may contain particulate matter, identified as glass and silicone material. “The administration of glass or silicone particulates may result in local irritation or swelling in response to the foreign
Drugs
FDA has approved a Shionogi NDA for Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist for treating thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Approval was based on safety and efficacy data from two Phase 3 clinical
Devices
Modulated Imaging has received FDA clearance for its Clarifi Imaging System, a diagnostic device that uses spatial frequency domain imaging to help clinicians assess tissue function and compromised circulation by measuring oxygenation and hemoglobin levels in superficial tissue. The diagnostic information can be used in assessing, managing and treating several
Drugs
A 1/31-2/27 FDA inspection at BioDiagnostic International, Brea, CA, found significant violations of the Federal Food, Drug, and Cosmetic Act and of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Specific violations cited in a 7/12 Warning Letter were: * failing to have separate or defined
Drugs
FDA has granted Daiichi Sankyo a breakthrough therapy designation for quizartinib, an investigational FLT3 inhibitor for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia, a very aggressive form of the disease associated with poor prognosis. Quizartinib is the first FLT3 inhibitor to significantly improve overall survival as
Drugs
FDA has released the FDA-483 issued following a 7/10-7/13 inspection at Sharp Drugs, a West Hampton Beach, NY, producer of sterile and non-sterile drugs. The inspection observations were: * ISO 5 classified aseptic processing area located within a non-classified room (segregated production area); * disinfecting agents,
FDA Policy/General
The New Civil Liberties Alliance (NCLA) says FDA should “cease its ad hoc promulgation of guidance by which it seeks to bind private parties with the force of law…. All externally binding rules must implement statutory instructions and be adopted through notice-and-comment rulemaking.” The group’s petition includes
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency will soon implement a new five-year blueprint for how it will build on existing programs to advance antimicrobial stewardship in veterinary settings. “We’ll expand on FDA’s existing actions, and launch some new programs,” he writes in a statement. “Our aim
Drugs
An 11/13-11/17/17 FDA inspection at the Yuki Gosei Kogyo drug manufacturing facility in Fukushima, Japan, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API), according to a 7/17 Warning Letter. The significant deviation cited in the letter was failure
FDA Policy/General
Federal Register notice: FDA is announcing the fee rates and payment procedures for medical device user fees for fiscal year 2019. Fee rates for FY 2019 PMA submissions ($322,147); 510(k) premarket notification submission ($10,953); panel-track supplement ($241,610); and de novo classification request ($96,644). The
FDA Policy/General
Federal Register notice: FDA has announced the rates for biosimilar user fees for fiscal year 2019. Fee rates for FY 2019 for the initial and annual biological product development fee ($185,409), for the reactivation fee ($370,818), for an application requiring clinical data ($1,746,745), for an application
Drugs
Americans for Homeopathic Choice and three of its top leaders are challenging an FDA draft guidance on homeopathy that says it intends to treat all homeopathic medicines as if they are “new drugs.” In a citizen petition, the group says it believes that homeopathic medicines fall under the 1938 definition
Drugs
A 12/7-12/27/17 FDA inspection at Milbar Laboratories, East Haven, CT, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/23 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility and authority to
Drugs
FDA has released a draft guidance, Draft Guidance on Fluticasone Propionate, that recommends in vitro and in vivo studies to establish bioequivalence of the test and reference metered dose inhalers containing fluticasone propionate. For in vitro studies, the document recommends that studies be conducted for all strengths of the test
Drugs
An Illinois federal court has entered a permanent injunction against three related Chicago companies — Global Marketing Enterprises, Lifeline Nutrients Corp., and Pronto Foods Company — and their owner Eduardo Chua and operations manager Haidee Dawis. The Justice Department says the injunction prevents the defendants from manufacturing, selling, and distributing adulterated and