Drugs
CareFusion has recalled AVEA Ventilator because of a faulty fuse on the ventilators’ alarm board, which may cause the device to unexpectedly shut down. If the ventilator shuts down, a patient may not receive necessary oxygen, which could cause serious adverse health consequences, including death, an FDA recall notice says.
Drugs
AdvaMed says that there are significant barriers to implementing the types of systems described in an FDA draft guidance on using electronic health record (EHR) data in clinical investigations, including lack of interoperability of the systems between healthcare systems. “Some systems are not designed to communicate with other systems,” the
Drugs
Four groups representing those working in long-term care (LTC) pharmaceutical settings say that an FDA draft guidance on repackaging could impose inappropriate new requirements that may conflict with existing regulation. Oblivious to the voluntary nature of FDA guidances, a statement from the Senior Care Pharmacy Coalition (SCPC), American Society
Drugs
FDA says that Talon Compounding Pharmacy, San Antonio, TX, is recalling all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by the pharmacy due to the agency’s concern about a lack of sterility assurance. An agency statement says that although there have been no complaints of illness
Drugs
FDA’s medical product safety surveillance system, Sentinel, has passed the first performance test of its modular program tools as part of a multi-effort assessment to validate their usefulness as surveillance measures. The test was conducted by FDA and other research partners to determine the extent to which a
Drugs
AbbVie says that an FDA draft guidance on developing direct-acting antiviral (DAA) drugs for treating hepatitis C routinely uses the term “resistance associated substitutions” for the specific viral genome position changes that confer resistance. The company’s comment letter says that the term “resistance associated variants” is commonly used
Drugs
FDA has approved an AbbVie NDA for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) tablets, a once-daily, extended-release co-formulation of the active ingredients in Viekira PAK for treating patients with chronic genotype 1 (GT1) hepatitis C virus infection, including those with compensated cirrhosis (Child-Pugh A). The
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) say that federal regulations governing information-sharing about medicines have not kept pace with data-driven medicine and need to be updated. In a joint online blog post, representatives of the two stakeholder groups write that there
Drugs
Attorney Chittam Thakore (Womble Carlyle) says that since biosimilar litigation is poised to gain momentum, early court decisions on rudimentary although fundamental questions about the Biologics Price Competition and Innovation Act (BPCIA) will be guiding lawyers and companies as they decide “whether to dance.” Writing in an online blog post,
Drugs
A 3/3-14 FDA inspection at ALK-Abello A/S, Horsholm, Denmark, found deviations from current good manufacturing practice requirements in the manufacture of licensed biological drug products and intermediates, according to a 7/15 Notice of Violation. The letter says that significant violations shown on an FDA-483
Drugs
A federal grand jury has returned an indictment charging two Florida residents and one North Carolina resident with manufacturing and distributing performance-enhancing drugs in violation of FDA regulations. William Bagwell (Petersburg, FL), Cole Leggett (Clearwater, FL) and Robert Nicholson-Gould (Lexington, NC) allegedly conspired to manufacture and distribute various
Drugs
FDA says it has approved safety labeling changes for fluoroquinolone antibiotics to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. An agency news release says that while the drugs are effective in treating serious
Drugs
The stakes are increasing for drug, biologic and medical device companies exposed to False Claims Act (FCA) lawsuits that are often brought by whistleblowers. Effective 8/1, the Department of Justice (DoJ) will nearly double the per-claim penalties it imposes under the FCA. According to a recent interim final
Drugs
Alzheon says it is moving its Alzheimer’s disease drug candidate (ALZ-801) into a pivotal Phase 3 program after reporting positive results from two Phase 1b studies. ALZ-801 is an optimized prodrug of tramiprosate, according to the company. The Phase 1b study results demonstrated “favorable gastrointestinal tolerability, consistent
Drugs
Drug manufacturing process reviews by CDER’s Office of Process & Facilities are being integrated with the facility evaluations, Division of Process Assessment branch chief Ubrani Venkataram told a 7/22 CDER Office of Pharmaceutical Quality Symposium webinar. The ongoing integration project is a top priority for the Office and
Drugs
One of the common deficiencies cited during drug preapproval inspections is inadequate process design or justification for the commercial process/control strategy, CDER Office of Pharmaceutical Quality Division of Inspectional Assessment quality assessment lead Quallyna Porte told a 7/22 Pharmaceutical Quality Symposium webcast. Porte said inspection teams typically have
Drugs
Continued government losses in lower courts involving First Amendment-related off-label drug marketing cases raise the specter that FDA’s entire pre-market approval regime could be in jeopardy, according to University of Arizona law professor Christopher Robertson. Writing in an Arizona Legal Studies discussion paper, Robertson notes how
Drugs
FDA has lifted a clinical hold affecting a Novartis/GenVec Phase 1-2 clinical trial of CGF166 in patients with severe to profound hearing loss. In January, Novartis told GenVec that enrollment in the trial had been stopped in accordance with criteria in the trial’s protocol. In April, Novartis
Drugs
Deficiencies cited during a preapproval inspection at an Ocular Therapeutix manufacturing facility has led to a FDA complete response letter for its NDA on Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use in treating ocular pain occurring after ophthalmic surgery. The letter raised concerns pertaining to unspecified deficiencies in
Drugs
FDA has given Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The agency’s letter cited GMP deficiencies documented during a preapproval inspection at Bausch
Drugs
The HHS Inspector General says that FDA is issuing more postmarketing study requirements (PMRs) to drug sponsors but continues to have problems with its data management system and work processes, which hinder its ability to track those requirements. The report says that in 2006 the Inspector General found that the
Drugs
Now that CDER reviewers are accompanying ORA investigators as part of the drug preapproval inspection team, some of the questions being asked during the inspections are seeking answers to issues typically communicated in NDA/BLA/ANDA review “information request” letters. This was a complaint raised during a Pharmaceutical Quality Symposium