Devices
FDA has cleared a Companion Medical 510(k) for the InPen system, its wireless-enabled insulin pen and proprietary mobile application. The device includes technology to calculate and recommend optimal dosing, track history and timing of doses, monitor insulin temperature, and track and report to the health care providers, according
FDA Policy/General
Federal Register Notice: FDA is announcing the rates and payment procedures for fiscal year 2017 animal drug user fees: $350,700 for an animal drug application; $175,350 for a supplemental animal drug application for which safety or effectiveness data are required and for an animal drug application subject to
FDA Policy/General
Federal Register Notice: FDA is announcing the fee rates and payment procedures for fiscal year 2017 generic new animal drug user fees: $232,400 for each abbreviated application for a generic new animal drug other than those subject to the criteria in section FDCA 512(d)(4); $116,200 for
FDA Policy/General
Federal Register Notice: FDA is establishing a public docket for comment on the agency’s blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood
FDA Policy/General
Federal Register Notice: FDA is announcing the rates for prescription drug user fees for fiscal year 2017: for an application requiring clinical data ($2,038,100), for an application not requiring clinical data or a supplement requiring clinical data ($1,019,050), for an establishment ($512,200), and for a
Devices
FDA has issued a guidance, General Wellness: Policy for Low Risk Devices, to clarify the CDRH compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). In it, the agency says CDRH does not intend to examine these products to determine whether they are devices within
Drugs
Four FDA National Center for Toxicological Research staffers say that it is likely that some cancer drugs could be repositioned to treat rare diseases. In an opinion article in the journal Trends in Pharmacological Sciences, the four look at the possible association between cancers and rare diseases across clinical observation,
Drugs
A review of cancer drugs approved by FDA between 1998 and 2014 found that a personalized approach for drug development was associated with faster clinical development, according to an online study report in Impact Journals. Researchers also reported no differences in access to FDA expedited review programs between personalized and
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
Devices
FDA has cleared an Instrumentation Laboratory 510(k) for the HemosIL HIT-Ab(PF4-H) assay for use on ACL TOP Hemostasis Testing Systems for detecting antibodies associated with heparin-induced thrombocytopenia. According to the company, this severe immunologic adverse reaction to a heparin complex can cause blood clots to
FDA Policy/General
Federal Register Notice: FDA is announcing the rates for ANDAs ($70,480), prior approval supplements to an approved ANDA ($35,240), drug master files ($51,140), generic drug active pharmaceutical ingredient facilities ($44,234), foreign API facility ($59,234), and finished dosage form facilities ($258,646) and foreign finished dosage
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance: Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices. The agency is issuing this draft guidance to clarify how it evaluates real-world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Adaptive Designs for Medical Device Clinical Studies. It provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device
FDA Policy/General
Federal Register Notice: FDA will hold a meeting 10/13 of the Vaccines and Related Biological Products Advisory Committee. The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza
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
Devices
FDA has cleared a 4WEB Medical 510(k) for its Lateral Spine Truss System, a 3D-printed lateral interbody fusion device. “4WEB’s proprietary truss implant technology leverages fundamental engineering principles in structural mechanics to address important clinical issues such as implant subsidence after lateral access surgery,” a news release