Devices
FDA has posted a new draft guidance on “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” that identifies specific considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices.
Devices
A Duval law firm client alert discusses the importance of 510(k) submitters persuading FDA that chosen indications for use fall under the umbrella of the chosen intended use statement. If they do not, the subject device will be found “not substantially equivalent.” The alert cautions that “FDA frequently interprets
Drugs
FDA has posted a Form 483 from a December inspection of drug compounder Elkhart Pharmacy (Elkhart, TX). The inspection cited the firm over its aseptic processing areas and the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. “Specifically, your firm does not use a sporicidal
Drugs
FDA has accepted for review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) that seeks to add to the approved label cardiovascular (CV) risk reduction data from the landmark EMPA-REG OUTCOME trial. “Cardiovascular complications can have a significant impact on the health and life expectancy of
Drugs
New England Journal of Medicine editors say they will only accept articles whose authors commit to make available the underlying data supporting reported results within six months after publication. “In the process of formulating our policy, we spoke to clinical trialists around the world,” a NEJM editorial says. “Many were
Devices
FDA has cleared an Entrotech Life 510(k) for its ChloraDerm, an edge-to-edge transparent film dressing to provide a chlorhexidine matrix for wound and catheter site protection for up to seven days. “Compared to common non-antimicrobial dressings ChloraDerm demonstrates substantially greater effectiveness against multi-drug-resistant organisms
Biologics
FDA has accepted for review an AstraZeneca and Valeant Pharmaceuticals BLA for brodalumab injection, a monoclonal antibody that targets the IL-17 receptor for treating patients with moderate-to-severe plaque psoriasis. The agency has set a user fee review target date of 11/16. The submission is supported by
Drugs
FDA and Commonwealth Informatics have signed a two-year research collaboration agreement (RCA) to enhance the Commonwealth Clinical Data Analytics (CCDA) platform for analyzing drug safety data. The platform is used by healthcare and medical product researchers to rapidly access, transform, explore and analyze multiple data sources. Under the agreement,
Drugs
FDA has approved a Bristol-Myers Squibb NDA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. The indication was approved under the agency’s accelerated approval program based on progression-free survival (PFS)
FDA Policy/General
BIOLOGICS Panel to Discuss Remicade Biosimilar Federal Register Notice: FDA’s Arthritis Advisory Committee will meet 2/9, from 7:30 a.m. to 5 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. The committee
Drugs
CDER plans to publish four guidance documents this year related to drug industry advertising and promotional activities, along with dozens of other guidances related to biosimilar submissions, conducting clinical trials and manufacturing quality. According to a just-posted guidance agenda, the documents planned for advertising are: * Health Care Economic Information
Devices
St Jude Medical Cardiac Rhythm Management Division has begun a Class 1 recall of its Optisure Dual Coil Defibrillation Leads, Model Numbers LDA220, LDA220Q, LDA230Q, and LDP220Q, which are designed for long term attachment to an implantable cardioverter defibrillator. A recall notice says leads may have been compromised during the
Devices
Advanced Medical Technology Association (AdvaMed) says FDA needs to provide more input on device manufacturing site change submissions. In just-posted comments on an FDA draft guidance on “Manufacturing Site Change Supplements: Content and Submission,” the group says more details are needed on the types of manufacturing site changes that
FDA Policy/General
Federal Register Notice: FDA is renewing the Pharmaceutical Science and Clinical Pharmacology Advisory Committee (formerly known as the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology). The new charter will be in effect until 1/22/18. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices. It informs industry and FDA staff of the its recommendations for identifying, addressing, and monitoring cybersecurity vulnerabilities and exploits for postmarket management of medical devices. To download this guidance, click here. To
FDA Policy/General
Federal Register Notice: FDA is correcting a 1/19 Federal Register notice announcing the Arthritis Advisory Committee meeting set to discuss a Celltrion Inc. BLA for a proposed biosimilar to Remicade. The notice contained an incorrect date for individuals requesting oral presentations, and for FDA notifying individuals on their request
FDA Policy/General
Federal Register Proposed order: FDA proposes an administrative order to reclassify the cranial electrotherapy stimulator (CES) device intended to treat insomnia and/or anxiety, a preamendments Class 3 device, into Class 2 (special controls). The devices would be subject to premarket notification and FDA would require the filing of a
Devices
FDA has cleared an Intuitive Surgical 510(k) for an integrated operating table motion claim for the da Vinci Xi Surgical System. Integrated table motion combines the da Vinci robotic-assisted surgical system and Trumpf Medical’s advanced operating table, the TruSystem 7000dV, to allow surgeons and anesthesiologists the ability
Drugs
FDA has approved Allergan’s Botox (onabotulinumtoxinA) for treating lower limb spasticity in adult patients to decrease the severity of increased stiffness in ankle and toe muscles. The drug was first approved in 2010 for treating upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers.
Drugs
United Therapeutics has petitioned FDA urging it to require strict bioequivalence standards for generic copies of its Tyvaso (treprostinil) inhalation solution. Tyvaso is a drug-device combination product indicated for treating pulmonary arterial hypertension in patients with specific symptoms to increase walk distance. The petition, filed by the law firm
Drugs
FDA has approved an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus FDA has approved an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus dexamethasone for treating patients with relapsed or refractory multiple myeloma
Drugs
FDA says it is “conferring” with European regulators after a Phase 1 trial, conducted by French clinical research organization Biotrial, resulted this week in the death of one enrolled patient and neurological injury to four others. The study involved Portuguese company Bial’s BIA 10-2474 and its use in