FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.” The document describes four policies intended to help sponsors develop Covid-19 tests during the public health emergency. Two of these address policies for accelerating the development of
Drugs
A Democratic-introduced bill this week contains several provisions affecting FDA that, even though the bill is expected to stall, are likely to be under consideration in the next coronavirus package with which the House and Senate come to terms, according to the Alliance for a Stronger FDA. The Trump
Drugs
Three months ahead of schedule, FDA 5/15 approved a Deciphera Pharmaceuticals NDA for Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor. The drug is indicated for adult patients who have received prior treatment with three or more
Drugs
FDA has issued Blueprint Medicines a complete response letter for its NDA for avapritinib, indicated for treating adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). The company did not disclose FDA’s reasons for the letter or whether is requested any additional data or clinical trials. Avapritinib
Drugs
The Eastern Oklahoma federal court has entered a temporary restraining order against Xephyr LLC, doing business as N-Ergetics, and three company officials that requires them to immediately stop distributing colloidal silver products. The company offered the products for sale to treat coronavirus and other diseases. In granting the order,
Drugs
FDA has denied a 1/22 Crowell & Moring petition asking that it not finalize with states a drug compounding memorandum of understanding (MOU) or take any regulatory action against drug compounders based on a regulatory definition of “distribution” that includes “dispensing” until conditions specified in the petition are met.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB and information collection extension entitled “Electronic Products” (OMB Control Number 0910-0025). FDA’s regulations give it authority to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards to control the emission
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0800). The collection is being revised to include reference to the guidance entitled “Pharmacy Compounding of Human
Drugs
FDA says it has updated its guidance for pharmacy compounders who experience shortages due to the Covid-19 public health emergency of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. An agency notice says the update clarifies that
Devices
FDA has posted a new Web resource page on thermal imaging systems, also known as infrared thermographic systems or thermal imaging cameras. The page specifically discusses thermal imaging systems and Covid-19, saying that scientific studies support that certain telethermographic systems may be used to measure surface skin temperature. “When
Devices
A 1/27-2/3 FDA inspection at Ideal Implant Inc., a Dallas, TX, manufacturer of the Ideal Implant saline-filled breast implant, identified Quality System Regulation and Medical Device Reporting violations. A 5/14 Warning Letter says specific violations were: * failing to maintain complaint files and to establish and
Devices
FDA says that Allergan is not meeting the post-approval study requirements associated with its Natrelle silicone-filled breast implants (round responsive implants) and Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants. A 5/14 Warning Letter says the studies were required to provide information on the long-
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 16 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
Drugs
Zealand Pharma has filed an NDA for HypoPal (dasiglucagon) rescue pen for treating diabetes patients with severe hypoglycemia. The submission is based on data from pivotal and confirmatory Phase 3 trials, where primary and all key secondary endpoints were successfully achieved with a median time to blood glucose recovery of
Devices
New York University (NYU) researchers say Abbott Laboratories’ ID Now Covid-19 rapid test missed a third of the samples detected positive by Cepheid’s Xpert Xpress SARS-CoV-2 test. Abbott’s test is frequently used at the White House to test visitors before entering the Oval Office. A
Biologics
The CBER Office of Compliance and Biologics Quality says Sparrow Health & Performance, Hoover, AL, has been offering on a Web site and Facebook page cellular products derived from adipose tissue as “stem cell therapy” to treat many diseases or conditions. A 5/11 notice of violation says that more
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))” (OMB Control Number 0910-0471). The collection supports FDA regulations that require manufacturers to report medical device-related deaths, serious injuries, and malfunctions. It also requires
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)” (OMB Control Number 0910-0616). The data collection relates to adherence to the legal requirements for submissions to the clinical trials registry and
Devices
CDRH Office of In Vitro Diagnostics policy analyst Allen Hill says the 510(k) third-party review program explained in a 3/12 guidance enhances quality in several ways. Speaking during a 4/16 Webinar on the guidance, Hill said the quality enhancements are that the agency has the right
Drugs
CBER has released the transcript from the 3/3 public workshop on facilitating end-to-end development of individualized therapeutics. At the workshop, CBER senior scientist Gopa Raychaudhuri said the session would focus on individualized therapeutic products regulated by CBER, specifically gene therapies and phage therapies. “We work in close
Drugs
FDA has issued a refusal to file letter to Bristol Myers Squibb and Bluebird Bio for a BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March. In the letter, FDA told the company that the BLA’s
Drugs
MasterPharm has recalled one lot of finasteride plus 1.25mg capsules because they were found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil was found when tested at an independent laboratory, according to a recall notice. Ingesting the