Drugs
The Association for Accessible Medicines (AAM) says a 12/17/20 FDA final guidance, Controlled Correspondence Related to Generic Drug Development, is informative but “does not adequately cover the process related to development of a generic drug-device combination product.” The association’s comment letter says that, as an example,
Devices
FDA has cleared a Brain Scientific 510(k) for its NeuroCap device, an advanced electroencephalogram (EEG) electrode array used to obtain rapid EEGs in routine clinical and research settings. The disposable pre-gelled EEG headset has 22 electrodes and 19 active EEG channels. “Pre-gelled, fixed electrode locations eliminate time
Drugs
Galapagos says that pooled interim results from the MANTA and MANTA-RAy safety studies for Jyseleca (filgotinib) demonstrate that treatment with Jyseleca for 13 weeks had no negative effect on sperm concentration when compared to placebo. GlobalData reports that pending outcomes from the two trials were key factors in FDA’
Drugs
FDA has cleared an Ultragenyx Pharmaceutical IND for UX053, an investigational mRNA therapy being evaluated for treating Glycogen Storage Disease Type III (GSDIII). Enrollment in a planned Phase 1/2 study is expected to begin in the second half of this year. The two-part clinical trial will see Part
Biologics
FDA has granted Kite accelerated approval for Yescarta (axicabtagene ciloleucel) for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Yescarta is the first chimeric antigen receptor T-cell therapy approved for patients with indolent FL, the company says. The approval
Drugs
FDA has told Soleno Therapeutics that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR (diazoxide choline) extended release tablets for treating Prader-Willi Syndrome (PWS). Late last year, the company met with FDA regarding the potential adequacy of data from previous studies with
Drugs
FDA has granted Viatria and Kindeva Drug Delivery tentative approval for budesonide/formoterol fumarate dihydrate, the first generic version of AstraZeneca’s Symbicort, indicated for certain patients with asthma or chronic obstructive pulmonary disease. The tentative approval was issued due to ongoing patent litigation. On 3/2, the West Virginia
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June 2020. FDA is also informing the public about the availability of basis of approval summaries and environmental review documents,
Devices
CDRH has announced a 4/13 workshop on how medical device developers can use consensus standards in premarket submissions. It will also discuss the agency’s Accreditation Scheme for Conformity Assessment (ASCA) Pilot, which is intended to improve the efficiency of conformity assessment in device reviews. Each session will provide
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is no longer maintaining an aggregated Web page of recent Warning Letters and Untitled Letters issued to drug marketers for advertising and promotion violations. The action is intended to align with FDA’s Warning Letter posting procedures, and thus the posting of
Drugs
Genentech says it is withdrawing the U.S. accelerated-approved indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer) after a required post-approval study failed to confirm its benefits in the patient population. Tecentriq’s indication withdrawal follows similar recent actions (see story) by
Devices
FDA has cleared a Cochlear Ltd. 510(k) for its new Cochlear Baha 6 Max Sound Processor for improving hearing outcomes for people with single-sided deafness, conductive or mixed hearing loss. The device is considered the smallest 55 dB sound processor, and it includes the ability to audio stream
FDA Policy/General
Federal Register notice: CDER is announcing the date that support will begin for version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide (SENDIG–DART) and version 1.6 of the CDISC Study Data Tabulation Model (SDTM)
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications” (OMB Control Number 0910-0810). The collection supports educational and public information programs relating to tobacco use. FDA regulations give it authority to conduct research
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of seven ANDAs from multiple applicants after they notified the agency that the drug products are no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Study of Multiple Indications in Direct-to-Consumer Television Advertisements.” The study will provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television advertisement. It will also explore whether similarity of
Devices
FDA has issued a device safety alert on thermal imaging systems intended to measure human body temperature because improper use could provide inaccurate temperature readings. These devices (telethermographic systems, infrared thermographs, thermal cameras, and fever cameras) are being used for temperature assessments and triage of individuals for elevated temperatures in
Devices
FDA has issued Cue Health an emergency use authorization for its Cue Covid-19 Test for home and over the counter use. The molecular nucleic acid amplification test is the first molecular test authorized for at-home use without a prescription, an agency release (XXINSRT LINKXX) says. It is intended
FDA Policy/General
FDA acting commissioner Janet Woodcock seems relieved that FDA is getting back to normal and putting the memory of political pressures from the Trump Administration behind it. Asked during an interview on NPR’s All Things Considered about what has changed now that she is temporarily in charge of the
Drugs
FDA is warning against the use of ivermectin to treat Covid-19. “The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses,” the agency alert says, adding that it has not reviewed data to support ivermectin’
Drugs
FDA has accepted for review an Ocular Therapeutix supplemental NDA for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for treating ocular itching associated with allergic conjunctivitis. The agency has set a user fee review action target date of 10/18. Dextenza is currently approved for treating ocular inflammation and pain
Devices
FDA has granted MedAlliance a breakthrough designation for its Selution SLR, a sustained drug-eluting (sirolimus) catheter for treating atherosclerotic lesions in native coronary arteries. FDA awarded the designation for improving luminal diameter in patients with atherosclerotic lesions in native coronaries, the company says. MedAlliance says the technology involves “unique