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FDA has revised a 2015 draft guidance on “Gastroparesis: Clinical Evaluation of Drugs for Treatment.”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
Drugs
FDA has issued a final guidance, Child-Resistant Packaging Statements in Drug Product Labeling, to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging statements in their drug product labeling. The document discusses what information should be included to support child-resistant packaging statements in labeling
Drugs
Attorney Kellie Combs (Ropes & Gray) says that while FDA wants to work with industry on incorporating elements of real-world evidence (RWE) in drug development programs, many in industry have said it’s not likely that industry will start to conduct a lot of RWE studies until there is
Devices
FDA has cleared a SpineWelding 510(k) for its Elaris Pedicle Screw System, which is intended to provide immobilization and stabilization of spinal segments through posterior, non-cervical, pedicle fixation in skeletally mature patients as an adjunct to fusion. The device is indicated for use in treating degenerative disc disease,
Drugs
A group of U.S. Senate Democrats is urging FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting “manipulated” data (see story) with recently approved Zlogensma, a gene therapy product intended to treat children less than two years old with spinal muscular atrophy. The agency says it was
Devices
FDA has cleared a Shimadzu Medical Systems 510(k) for the Fluorospeed X1 patient side conventional radiographic/fluoroscopic (RF) table system. The device offers high image bariatric and routine daily fluoroscopic and radiographic exams, according to the company, including chest, abdomen, or extremities along with upper GI’s, modified swallows
Drugs
Federal Register notice: FDA has extended the comment period on a 7/9 notice about a public meeting entitled “Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Request for Comments.” Comments are now being accepted until 9/16. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced an 11/7 public meeting entitled “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs.” The meeting will seek specific, actionable policy suggestions that could be implemented in the near-term by CDER’s review staff to promote
FDA Policy/General
Federal Register notice: FDA has announced an 11/7 public meeting entitled “Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA’s Office of New Drugs.” The meeting will seek specific, actionable policy suggestions that could be implemented in the near-term by CDER’s review staff to promote
FDA Policy/General
FDA has issued a warning against Miracle Mineral Solution (MMS) because it is illegally promoted as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. “However, the solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects,