Devices
FDA says it is seeking public input and comment on an updated version of its software precertification program working model. An update notice (contains links to the updated working model, the comment docket, and other resources) says the new version outlines these pre-certification program key components: Excellence Appraisal and
FDA Policy/General
Federal Register notice: FDA has published a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals — Questions and Answers.” The ICH document is intended to provide additional clarity about anticancer pharmaceutical development described in the ICH guidance “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals” that was published in 2010. To
Devices
FDA has cleared a B. Braun Medical 510(k) for its wireless second generation software for its Perfusor Space Syringe Pump. This is the first syringe pump with air and road transport in its cleared indications for use, according to the company. It is also integrated with DoseTrac, DoseGuard, and
Drugs
CDER deputy director for regulatory programs Douglas Throckmorton says IV fluid shortages that have existed since 2014 and were exacerbated by Hurricane Maria’s effect on Puerto Rican drug manufacturers in 2017 are finally easing. An agency news release says that “after much work and a great deal of collaboration
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it supports continued development of targeted therapies for molecularly defined conditions, it is important to avoid unintended consequences that might adversely affect orphan drug development. “If the incentives for development of products shift away from tumor histology to tissue agnostic
Drugs
FDA has lifted a clinical hold against Solid Biosciences’ Phase 1/2 clinical trial for its investigational microdystrophin gene transfer, SGT-001, for treating Duchenne muscular dystrophy. In its letter, the agency acknowledged that the company satisfactorily addressed all clinical hold questions. Solid Biosciences has begun activities to resume the
Devices
FDA has cleared an Arcuro Medical 510(k) for its SuperBall meniscus repair system. The all-suture device is intended to preserve knee functionality and features “no knot in the joint space,” according to the company. Arcuro says it expects to convert a significant portion of the meniscus removal procedures
Drugs
FDA has issued a clinical hold on a Ziopharm Oncology Phase 1 trial to evaluate CD19-specific CAR-T therapies manufactured under point-of-care, and requested additional information to support the IND. The clinical trial is intended to evaluate CAR T cells manufactured with “Sleeping Beauty” technology as an
Drugs
University of Ottawa law professor Amir Attaran has suggested that the Canadian government should look at suspending U.S. drug patents as the Trump Administration turns up the heat on its trade dispute with Canada. The U.S. holds more pharmaceutical patents and other intellectual property licenses than any other
FDA Policy/General
Federal Register notice: FDA has established a public docket to receive information, recommendations, and comments on matters related to its publication of technical specifications for the specific use of data standards in drug/biologic submissions. To view the notice, click here.
Drugs
Federal Register notice: FDA is announcing an opportunity for public comment on an information collection extension for the agency guidance entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” (OMB Control Number 0910–0802). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” The document notes that there is an unmet medical need among EB patients due to the paucity of effective treatment options. To view the notice, click here.
Drugs
FDA has issued Ortho Dermatologics a complete response letter on its NDA for Duobrii (halobetasol propionate and tazarotene) lotion and its use in treating plaque psoriasis. The letter did not cite any deficiencies related to the product’s clinical efficacy or safety, and only noted questions regarding pharmacokinetic data, according
FDA Policy/General
Class 2 for Prostate Tissue Jet System Federal Register notice: FDA classifies the fluid jet system for prostate tissue removal into Class 2 (special controls). 06/15/2018 Draft Guide on Certain Guidewire Submissions Federal Register notice: FDA makes available a draft guidance entitled “Coronary, Peripheral, and Neurovascular Guidewires — Performance
Drugs
FDA has made available a guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” The document focuses on drug development and trial design issues specific to treating EB, including FDA’s current thinking on endpoint considerations. It notes that there is “not yet sufficient clinical trial precedent
FDA Policy/General
Federal Register notice: FDA has classified the fluid jet system for prostate tissue removal into Class 2 (special controls). The agency has identified it as a prescription device intended for the resection and removal of prostatic tissue for treating benign prostatic hyperplasia. It cuts tissue by using a pressurized jet
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Coronary, Peripheral, and Neurovascular Guidewires — Performance Tests and Recommended Labeling.” The document provides recommendations for the information and testing that should be included in premarket submissions for such devices. To view the notice, click here.
Drugs
FDA has posted an ICH guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers.” The document is intended to address challenges sponsors have experienced when implementing recommendations on nonclinical evaluation for anticancer pharmaceuticals. It also encourages reducing, refining and replacing the use of animals in clinical trials.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations.” The document addresses labeling considerations for devices containing lubricious coatings that are used in the vasculature. It also provides recommendations for information to be included in device labeling
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of two Ferring Pharmaceuticals ANDAs because the company notified the agency that they were no longer marketed. The withdrawn products are Menotropins (follicle-stimulating hormone/luteinizing hormone) for injection, 75 IU/75 IU per vial and Menotropins 150 IU/150 IU per vial.
Devices
FDA has approved Medtronic’s 200mm and 250mm lengths of its In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions in patients with peripheral artery disease. Approval was based on clinical data from the complex lesion imaging cohorts of the company’s In.PACT Global Study,