Biologics
FDA has expanded the emergency use authorization for Pfizer-BioNTech’s Covid-19 vaccine to include adolescents aged 12 through 15 years. The expanded EUA was based effectiveness data showing the vaccine was 100% effective in preventing Covid-19. FDA says no cases of Covid-19 occurred among 1,005
Devices
FDA has cleared a Bolder Surgical 510(k) for an expanded indication for the CoolSeal Trinity 5 mm Laparoscopic Vessel Sealer, Divider, and Dissector to include surgical procedures for pediatric patients including infants, children, and adolescents. “The larger vessel sealing capacity and cutting functionality of CoolSeal Trinity complements the 3
FDA Policy/General
OMB Approves 6 FDA Information Collections 5/7/2021 Federal Register notice: FDA has announced the following information collections have been approved by OMB: * Applications for FDA Approval to Market a New Drug (0910-0001) * Medical Devices; Humanitarian Use Devices (0910-0332) * Medical Devices; Device Tracking (0910-0442) * Dispute Resolution
FDA Policy/General
Federal Register notice: FDA has announced the following information collections have been approved by OMB: * Applications for FDA Approval to Market a New Drug (0910-0001) * Medical Devices; Humanitarian Use Devices (0910-0332) * Medical Devices; Device Tracking (0910-0442) * Dispute Resolution Procedures for Science Based Decision on Products Regulated by
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” (OMB Control Number 0910-0856). The collection supports FDA regulations that govern drug and device labeling and prescription drug and restricted device advertising.
Biologics
Pfizer and BioNTech have begun a rolling BLA to seek full approval of their mRNA vaccine to prevent Covid-19 in individuals 16 years of age and older. Currently the vaccine is being manufactured and distributed under an emergency use authorization due to the pandemic-related health emergency. Data to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB and information collection extension entitled “Class 2 Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” To view the notice, click here.
Drugs
An FDA advisory committee has voted 9 to 9 on whether the efficacy data support approval for a ChemoCentryx NDA for avacopan, indicated for treating adult patients with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. Panel members were mixed on the adequacy of a single Phase 3 trial submitted to
Devices
FDA has granted Viome a breakthrough device designation for its proprietary mRNA analysis technology combined with its next-generation artificial intelligence (AI) platform for use in early detection of oral and throat cancer. The device uses saliva as a “liquid biopsy” to analyze samples for the presence of oral squamous
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “513(g) Request for Information” (OMB Control Number 0910-0705). The collection supports FDA regulations and guidance related to obtaining the agency’s views about the classification and regulatory requirements that may be applicable to a particular
Drugs
FDA has accepted and will give priority review to two applications from Merck and Eisai for the combination of Merck’s Keytruda (pembrolizumab) and Eisai’s Lenvima (lenvatinib) for the first-line treatment of patients with advanced renal cell carcinoma and for the treatment of patients with advanced endometrial carcinoma
FDA Policy/General
Federal Register notice: FDA has announced a 6/9 Pharmacy Compounding Advisory Committee meeting. Panel members are scheduled to discuss four bulk drug substances nominated for inclusion on the 503A Bulks List — choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin. To view the notice,
Biologics
A professor of bioinorganic chemistry at England’s Keele University is petitioning FDA to assure accurately reported and consistent levels of aluminum in Adacel, Bostrix, Energix-B, Havrix, Infanrix, Infanrix hexa, Kinrix, Pediarix, Pedvax-HIB, Pentacel, Prevnar-13, Synflorix, and Vaqta. The petition submitted by Christopher Exley calls on FDA
Drugs
The Supreme Court should hear the appeal of a Janssen case in which the Philadelphia Court of Common Pleas held the company liable for not adding warnings about specific risks of off-label uses associated with one of its drugs. That’s the view of American Tort Reform Association president
Drugs
Some 20 House members, led by Reps. Mikie Sherrill (D-NJ) and Adam Kinzinger (R-IL) have sent a letter to the House Appropriation Committee and its Subcommittee on Agriculture, Rural Development, and FDA, asking that the committee not include any language in the FY 2022 appropriations bill that would
Devices
FDA has cleared a Medo 510(k) for its Medo-Thyroid, an artificial intelligence (AI) device intended to simplify thyroid ultrasound scanning workflow. The device allows users to obtain quick video “sweeps” of each side of the thyroid gland, according to Medo. It then uses AI to automatically review the
Devices
FDA has announced a 5/20 Webinar to share information and answer questions about its medical device Accreditation Scheme for Conformity Assessment (ASCA) Pilot. Under the pilot, the agency grants ASCA recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies. The Webinar
Biologics
The CBER Office of Compliance and Biologics Quality says the Ramos Chiropractic and Wellness Center, Burlington, CO, which does business as Rejuvenate Stem Cell Center, markets through its Web sites “umbilical stem cells” from BioGenix for various diseases or conditions. A 5/4 Notice of Violation says the company’s
Drugs
FDA has just released the FDA-483 issued following a 12/9-12/17/20 inspection at the Hospira sterile drug manufacturing facility in McPherson, KS. The 10 inspection observations on the form were: * failing to fully follow the responsibilities and procedures applicable to the quality control unit; * failing to
Drugs
Incyte has agreed to pay $12.6 million to resolve allegations that it violated the False Claims Act by paying kickbacks. The Justice Department says the settlement resolves allegations that from 2011 through 2014 the company “purportedly used an independent foundation as a conduit to pay the copays of certain
FDA Policy/General
FDA acting commissioner Janet Woodcock says the agency has developed scenarios with assumptions that can inform a return to more traditional inspection activities. In a report, “Resiliency Roadmap for FDA Inspectional Oversight,” Woodcock says the agency “experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our
Drugs
An internal Eli Lilly complaint says that a factory executive changed technical documents required by government regulators to downplay serious quality control problems at the facility that makes the company’s Covid-19 therapy. Reuters reports in an exclusive story that the complaint involves Lydia Wible, an executive at the