Devices
Attorney Bradley Thompson (Epstein, Becker & Green) says he is hearing industry enthusiasm for FDA’s new software precertification program but not enough discussion about the program’s heavy cost to industry. “FDA wants more power. A lot more,” he writes. “And I for one am worried.” Thompson says the
Drugs
FDA has approved a Relypsa supplemental NDA for Veltassa (patiromer) for oral suspension in treating hyperkalemia. The label update is based on results from the Phase 4 TOURMALINE study, which showed no statistically significant difference between the groups taking Veltassa with or without food in achieving serum potassium levels within
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biotek Inc. Layton, UT (3/13): FDA inspected the firm 8/2017 and cited it over product claims that cause its dietary supplements to be unapproved drugs. For example,
Drugs
FDA says that AuroMedics Pharma is recalling two lots of ampicillin and sulbactam for injection USP 3 grams/single-dose vial to the hospital/user level due to the presence of visible particulate matter. The agency post of a company statement says the recall follows customer complaints about the presence
Drugs
FDA has hinted that it is working on a guidance on manufacturer communications about their products under the First Amendment. In her annual address to the Food and Drug Law Institute, FDA chief counsel Rebecca Wood noted that there has been great interest in the parameters of a firm’s
Devices
FDA has permitted the de novo marketing of Wilson-Cook Medical’s Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract. The device is an aerosolized spray that delivers a mineral blend to the bleeding site. It is applied during an endoscopic
Devices
FDA has approved a CardioFocus PMA for the HeartLight Excalibur Balloon, a next-generation technology for treating paroxysmal atrial fibrillation. The device, which is intended to advance the company’s technology used in its FDA-approved HeartLight Endoscopic Ablation System, introduces “an advanced feature set that optimizes the speed and
FDA Policy/General
Federal Register notice: FDA is correcting a 4/9 Federal Register notice about OMB approval of several information collection activities. The document was published with an incorrect docket number. The notice now is corrected to read docket number “FDA–2011–N– 0075.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn a 1/26/2018 direct final rule to amend its general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The withdrawal is necessary after FDA received significant adverse comment against the proposal. The agency will now
Devices
Terumo has recalled its Sarns TCM and TCM II Cooling and Heating Systems and HX2 Temperature Management Systems due to revised cleaning instructions. The heater-cooler devices are used during surgeries to warm or cool patients as part of their care. Terumo took this action in response to FDA’s
FDA Policy/General
FDA has qualified the Minnesota Living with Heart Failure Questionnaire from the University of Minnesota as part of its Medical Device Development Tools program. It aims to reduce regulatory burden by qualifying tools that can aid in developing and evaluating devices. Qualified tools can be used by industry to support
Drugs
Serenity Pharmaceuticals has petitioned FDA asking it to deny a pending Ferring NDA for Nocdurna (desmopressin) 25 mcg and 50 mcg sublingual administration for treating nocturia. Serenity is the NDA holder for Noctiva (desmopressin acetate) nasal spray. In the petition, Serenity requests that FDA deny approval because Ferring has not
Drugs
FDA has posted an Akorn Form 483 from a 2016 inspection at the firm’s Zurich, Switzerland sterile drug manufacturing facility. The five-item 483 cited the firm for failing to thoroughly review any unexplained discrepancy. It was also cited for not having the quality control unit’s responsibilities and
FDA Policy/General
FDA Withdraws 3 Sun Pharma ANDAs Federal Register notice: FDA withdraws three Sun Pharmaceutical Industries ANDAs because they are no longer marketed. 05/04/2018 9 No Longer Marketed ANDAs Withdrawn Federal Register notice: FDA withdraws the approval of nine ANDAs from multiple applicants. 05/04/2018 Needle Destruction Device
Drugs
FDA has approved a Novartis NDA for Tafinlar (dabrafenib) and Mekinist (trametinib) for the combination treatment of anaplastic thyroid cancer that cannot be removed by surgery or has spread to other parts of the body. The approval covers the drugs’ use in patients that have a type of abnormal gene,
FDA Policy/General
Federal Register notice: FDA has withdrawn three Sun Pharmaceutical Industries ANDAs because they are no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of nine ANDAs from multiple applicants. The application holders have notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a final order to reclassify the needle destruction device into Class 2 (special controls)and subject to premarket notification. The device has been renamed “sharps needle destruction device.” To view the notice, click here.
Devices
FDA has cleared a PeraHealth 510(k) for the PeraTrend, a predictive, real-time clinical surveillance technology. “PeraHealth solutions are powered by the Rothman Index (RI), a comprehensive measure of a patient’s condition for healthcare providers, leveraging data within a hospital’s existing electronic health record (EHR) to quantify
Devices
CDRH is proposing a complete overhaul of its medical device review, safety surveillance and compliance structure to move to a more total product lifecycle (TPLC) approach to its decision making. Speaking at the Food and Drug Law Institute’s annual meeting in Washington, DC 5/3, CDRH director Jeff Shuren
Drugs
FDA has released the FDA-483 issued following a 12/4-12/12/17 inspection at Akorn AG, Zurich, Switzerland, a finished drug product manufacturer. The four inspection observations were: * failing to establish and document the accuracy, sensitivity, and reproducibility of test methods; * separate or defined areas to prevent contamination
Drugs
FDA has issued a document answering what it says are questions frequently asked by industry about the agency’s clinical data summary pilot program. Questions are answered on what parts of a clinical study report FDA will make available, who redacts information and how that process operates, and who to