Devices
FDA has cleared a Molli Surgical 510(k) for Molli, a wire-free localization technology for breast cancer surgery. According to Molli, the device helps radiologists mark lesions quickly and accurately, and enables surgeons to locate and remove lesions more efficiently. It comprises an implantable marker, detection wand and visualization
Drugs
Acella Pharmaceuticals has recalled certain lots of its NP Thyroid (levothyroxine and liothyronine) in 9.5mcg/2.25mcg, 19mcg/4.5mcg, 38mcg/9mcg, 57mcg/13.5mcg, and 75mcg/18mcg tablets because routine testing has found them to be subpotent. The product contains less than 90% of the labeled amount of
FDA Policy/General
Federal Register notice: FDA has announced that an information collection entitled ‘‘Data to Support Drug Product Communications’’ has been approved by OMB. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Prescription Drug Advertising — 21 CFR Part 202” (OMB Control Number 0910-0686). The collection supports agency regulations and guidance requiring certain information in human prescription drug promotional labeling and advertisements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing a publication containing modifications to its list of standards FDA recognizes for use in premarket reviews. The publication, Modifications to the List of Recognized Standards, Recognition List Number: 055, is intended to assist manufacturers who elect to declare conformity with consensus standards to meet
Drugs
FDA and HHS are withdrawing a policy statement on drug review transparency that was issued in the final days of the previous administration. The 1/15 policy required FDA to publish annually for each NDA/ANDA approved the total days that elapsed between initial submission and approval. It is now
Drugs
Two bipartisan U.S. Senate bills have been introduced with the stated purpose of speeding the development of and improving access to lower-cost generic drugs. The bills, which were introduced by senators Bill Cassidy (R-LA) and Tina Smith (D-MN), are intended to make changes to the Food
Devices
Pacific Medical Group has recalled the Alaris Infusion Pump Module Model 8100 Front Bezel because components may crack or separate, leading to inaccurate delivery of fluids to patients. The pump is used to deliver fluids such as medications, nutrients, blood, and other therapies into a patient’s body in controlled
Drugs
FDA has issued Leo Pharma a complete response letter for tralokinumab and its use in adults with moderate-to-severe atopic dermatitis. The agency letter requested additional data relating to the therapy’s device component and did not request any new data on the clinical efficacy or safety of the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0858). The collection supports implementation of sections 503A and 503B of the Federal
Drugs
FDA has sent a complete response letter (CRL) to Biogen for its sBLA for a new subcutaneous route of administration of Tysabri (natalizumab) to treat relapsing multiple sclerosis. The company says it is evaluating the CRL and will determine the next steps.
Devices
AdvaMedDx says its members develop in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, enable early detection of disease, and reduce overall healthcare costs. In comments on an FDA guidance, Policy for Evaluating Impact of Viral Mutations on Covid-19 Tests, the association says its
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees” (OMB Control Number 0910-0581). The collection supports agency regulations and associated agency guidance requiring sponsors to monitor studies evaluating new drugs, biologics, and devices. To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Reporting — 21 CFR Part 803” (OMB Control Number 0910-0437). The collection supports FDA regulations and its Medical Device Reporting program that require user facilities, manufacturers, importers, and distributors of medical devices to report adverse
Devices
FDA has granted Lumenis a de novo authorization for its newest intense pulsed light device (IPL) for improving signs of dry eye disease due to meibomian gland dysfunction. The common disorder causes dry, gritty, burning, tired eyes and fluctuating vision, according to the company. The authorization was based on data
Drugs
A Government Accountability Office (GAO) analysis of selected branded drug prices prepared for the Senate Budget Committee says that for 20 selected branded prescription drugs, estimated U.S. prices at the retail level were more than two to four times higher than prices in Australia, Canada, and France. The report
Devices
FDA has cleared a Soliton special 510(k) for modifications to its Resonic device and its use for tattoo removal and cellulite treatment. The modifications pertain to an autoloading cartridge and an improved user interface, according to the company. The device uses rapid pulses of acoustic shockwaves for treating cellulite
Drugs
Academic medical center researchers from Yale and other institutions say older Americans and blacks are underrepresented in both premarketing and postmarketing trials for a variety of cancer therapeutics. “FDA should require demographic representation in premarketing and postmarketing studies that approximates the population expected to use the therapeutic by investing in
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Electronic User Fee Payment Request Forms — Form FDA 3913 and Form FDA 3914” (OMB Control Number 0910-0805). The forms are designed to provide the minimum necessary information for FDA to review and process a user fee
Devices
Pew Charitable Trusts is calling on HHS to reinstate FDA’s authority to require premarket reviews for laboratory-developed tests. Under the previous administration, an 8/2020 HHS notice (see earlier story) removed premarket reviews for such tests, including tests to detect the virus that causes Covid-19. The major
Drugs
FDA says it is aware that some prescribers and pharmacies have had difficulties recertifying in the modified Transmucosal Immediate-release Fentanyl (TIRF) risk evaluation and mitigation strategies (REMS) that was fully implemented 3/29. “FDA is working with manufacturers of TIRF medicines to address these concerns,” an agency notice says.
Drugs
FDA has granted priority review for Takeda’s NDA for mobocertinib (TAK-788) to treat adults with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer as detected by an FDA-approved test who have received prior platinum-based chemotherapy. The company says mobocertinib