Drugs
An FDA complete response letter for the FibroGen NDA for roxadustat to treat anemia of chronic kidney disease says the agency will not approve the NDA in its present form and requests additional clinical study before resubmission. The company says it and its partner, AstraZeneca, will be discussing next steps
Devices
FDA says its review of Web sites maintained by Vivera Pharmaceuticals, Mission Viejo, CA, determined that the firm is marketing Covid-19 antigen test kits in the U.S. A just-released 7/26 Warning Letter says the tests are offered for sale without marketing approval, clearance, or authorization from
Drugs
SterRx has recalled three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1,000 mL due to waterborne microbial contamination. Intravenous administration of contaminated product “could result in site specific infections as well as serious systemic infections which may be life-threatening,” a recall notice says. To date,
FDA Policy/General
CNN reports that the Biden administration has considered several people in its search for a permanent FDA commissioner who can win Senate approval and has come up short. “Two officials said it could be ‘weeks’ before Biden settles on anyone,” the online story says. The network reports the White House
Devices
FDA has cleared an Able Medical Devices 510(k) for its Mach Screw Clip System, a single-use, sterile screw delivery device. By clipping directly onto the Valkyrie Thoracic Fixation System, the the clip delivers screws fast and accurately for thoracic fixation, the company says. They are pre-loaded with
Devices
FDA has cleared a 3NT Medical 510(k) for its single-use Peregrine Drivable Ear Nose and Throat (ENT) Scope. The company says the device is designed to provide ENT surgeons with unparalleled views of the sinus anatomy to enhance their surgical experience. The scope allows ENT surgeons to access
Drugs
FDA has granted Lantern Pharma an orphan drug designation for LP-184 and its use in treating pancreatic cancer. The company says that the next generation alkylating agent works by damaging DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. The therapy
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees. The agency is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees. Nominees may be self-nominated or may
Drugs
The Court of Appeals for the Federal Circuit has affirmed an earlier ruling that Teva’s sale of carvedilol induced infringement of a GlaxoSmithKline method-of-treatment patent, even though the Teva product was approved and labeled only for non-infringing uses. A Patentlyo post (contains link to decision) says
Devices
FDA says its review of the Web site maintained by Captain’s Cloth, Laguna Niguel, CA, determined that the firm is marketing KN95 face masks manufactured by Lianyungang Manai Protective Equipment Co. Ltd. that are offered for sale in the U.S. without marketing approval, clearance, or authorization from FDA.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. They are: * Infant Formula Requirements (OMB control # 0910–0256) * Shortages Data Collection (OMB control # 0910–0491) * Guidance on Labeling for Natural
Drugs
A 3/22-3/26 FDA inspection at BBC Group, Pumei Town, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/4 Warning Letter says specific violations were: * failing to exercise appropriate controls over computer or related systems to assure that only authorized
Drugs
A 3/1-3/5 FDA inspection at Sanit Technologies (Durisan), Sarasota, FL, a drug manufacturing facility, found current good manufacturing practice (CGMP) regulation violations for finished drugs. A 7/27 Warning Letter says the specific violation was: * the firm’s quality control unit failed to exercise its responsibility to
Biologics
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Stem Cell Therapy of Las Vegas, Las Vegas, NV, and other online sources determined that the company markets to consumers cellular products derived from either human adipose tissue or umbilical cord. An 8/
Devices
FDA has cleared a Surround Medical Systems 510(k) for its Portray dental imaging system, a 2D diagnostic tool that allows 3D tomosynthetic and 2D synthetic imaging as adjunctive tools for producing diagnostic dental radiographs of teeth, jaw, and other oral structures. “The Portray system deploys multiple X-ray beams
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. BBC Group, Pumei Town, China (8/4): FDA inspected the firm 3/22-26 and cited significant GMP violations for finished drugs. The agency said BBC failed to exercise
FDA Policy/General
Federal Register notice: FDA has announced a 9/17 Pediatric Advisory Committee to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. Panel members are scheduled to review Cook Medical’s Flourish, a pediatric esophageal atresia device
FDA Policy/General
Federal Register notice: FDA has established a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between 9/2/2020 and 9/2/2021 on FDA’s Web site, but not presented at the upcoming 9/17 Pediatric Advisory Committee meeting. Comments
Drugs
KVK Tech has recalled two lots of atovaquone oral suspension, USP 750 mg/5mL based on customer complaints of unusual grittiness in the product, which the company has determined was most probably caused by prolonged exposure to extremely cold weather during shipment. Atovaquone is indicated to treat pneumocystis jiroveci pneumonia,
Biologics
FDA has accepted for review two Merck supplemental BLAs for its anti-PD-1 therapy Keytruda (pembrolizumab). One submission was accepted for priority review for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney)
Devices
FDA says Lepu Medical Technology, Beijing, China, is selling three Covid-19 test kits without marketing approval, clearance, or authorization from FDA. A 7/29 Warning Letter says the kits are adulterated because the firm does not have approved PMAs in effect for them. The kits also are misbranded because
Drugs
Attorney Patricia Kaufman says a new FDA final rule amending the “intended use” regulations for drugs and medical devices “may come as a disappointment to those who were hoping that FDA would provide more clarity in its regulations regarding permissible activities. However, it is not surprising that FDA is rejecting