FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Protection of Human Subjects; Informed Consent; and Institutional Review Boards (IRB) — 21 CFR Parts 50 and 56” (OMB Control Numbers 0910-0755 and 0910-0130). On its own in initiative, the agency is consolidating the information collections
Drugs
FDA has approved the Global Alliance for TB Drug Development’s Pretomanid tablets to be used in combination with bedaquiline and linezolid to treat a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant, or non-responsive multidrug resistant pulmonary tuberculosis. An agency statement says that
Drugs
FDA has issued Dr. Reddy’s Laboratories two complete response letters for generic copies of Teva’s multiple sclerosis drug Copaxone (glatiramer acetate injection) and Merck’s female contraceptive Nuvaring (etonogestrel/ethinyl estradiol) vaginal ring. Dr. Reddy’s declined to disclose the reasons for the FDA rejection letter, but said
Drugs
Federal Register notice of intent: FDA has announced its intention to begin inactivating drug listing records that are improperly listed in accordance with FDA requirements because these drug listings are not certified as being active and up to date or are associated with a manufacturing establishment that is not currently
Drugs
House Committee on Oversight and Reform chairman Elijah Cummings (D-MD) and Senate Budget Committee ranking member Bernie Sanders (I-VT) have written to three drug companies asking about their pricing of generic drugs and opening an investigation into what Cummings and Sanders say is the companies’ coordinated obstruction of
Devices
FDA has cleared Pollogen’s radiofrequency (RF) home-use device TriPollar Stop for treating the face and the neck to eliminate aging signs, reduce lines and wrinkles and improve skin strength, texture and elasticity. The device uses Pollogen’s triple-axis RF waves to introduce heat to the dermis, which
Drugs
The FDA Oncology Center of Excellence (OCE) and Syapse have signed a multi-year research collaboration agreement focusing on using real-world evidence (RWE) to support regulatory decision making. Syapse says that it and OCE “will work with stakeholders across FDA to address key regulatory questions about testing and treatment
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Gastroparesis: Clinical Evaluation of Drugs for Treatment.” The document provides the agency’s current thinking on clinical trial designs and clinical endpoint assessments to support developing such drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Child-Resistant Packaging Statements in Drug Product Labeling.” The document discusses the information that should be included to support child-resistant packaging statements in prescription and over-the- counter human drug product labeling. To view the notice, click here.
Devices
Forbes Technology Council member Charles Aunger is questioning whether FDA is the appropriate agency to exercise regulatory authority over artificial intelligence/machine learning (AI/ML)-based software as a medical device. Writing in a Forbes online post, Aunger says FDA has released a proposed framework and stated its intention to
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the National Mammography Quality Assurance Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 7/7/2021. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Q-Submission Program for Medical Devices” (OMB Control Number 0910-0756). The program provide mechanisms available to submitters through which they can request feedback from, or a meeting with, FDA about potential or planned medical device
Drugs
FDA has revised a 2015 draft guidance on “Gastroparesis: Clinical Evaluation of Drugs for Treatment.” The agency says new changes reflect its current thinking on developing clinical outcome assessment measures and statistical considerations for using those measures to assess primary and secondary efficacy endpoints of clinical trials for gastroparesis. The
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its guidance entitled “Medical Device Accessories” (OMB Control Number 0910-0823). The guidance describes FDA’s policy concerning the classification of accessories, and it explains what devices are generally considered an accessory. To view the notice, click
Drugs
Drug recalls decreased 18.1% to 77 in the second quarter of 2019, tied for the second lowest number over the past 10 quarters, according to the Stericycle Quarter 2 recall index. However, the report says that recalled units increased 86.3% to just under 24 million, almost double the
Drugs
FDA says it will begin inactivating drug listing records that are improperly listed in accordance with agency requirements because the drug listings are not certified as being active and up to date or are associated with a manufacturing establishment that is not currently registered with FDA. A Federal Register notice
Devices
A 3/11-3/28 FDA inspection at Talon, an S&S Technology company, in Houston, TX, found Quality System Regulations violations, including several repeated from a 2011 inspection, in the firm’s manufacturing of Class 1 and 2 medical equipment, healthcare supplies, and radiation products used for general
Drugs
A 2/11-2/20 FDA inspection at Emcure Pharmaceuticals, Maharashtra, India, found a significant violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/2 Warning Letter says the specific violation was: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any
Drugs
FDA says its review of additional data found no increased risk of prostate cancer with the use of entacapone (Orion’s Comtan and Stalevo) to treat Parkinson’s disease. An 8/13 drug safety communication, updating a 3/31/10 communication, says the agency’s recommendations for using Comtan (entacapone)
Drugs
Dalhousie University researcher Matthew Herder says that since FDA gradually shifted to a model of lifecycle regulation in the 1990s, it is not simply an agency in transition but rather an agency on guard against a set of larger political threats to its mandate. Writing in Milbank Quarterly, Herder says
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Emcure Pharmaceuticals, Maharashtra, India (8/2): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any
Devices
FDA has cleared a DynoSense 510(k) for its Vital Signs Measuring System, a cloud-based measuring and recording platform. The device captures electrocardiogram, respiration rate, oral body temperature, functional oxygen saturation of arterial hemoglobin, optical photoplethysmogram for pulse rate, and heart rate data. The company says it wirelessly communicates