Devices
FDA has cleared an Align Technology 510(k) for the iTero Element 5D Imaging System. The intraoral scanner features near-infrared imaging technology to scan the internal structures of teeth (enamel and dentin) in real time, the company says. Its visualization tools are intended improve patient engagement and communication to
FDA Policy/General
Federal Register notice: FDA has announced the process for making available FDA guidance documents related to the coronavirus outbreak. To act quickly, FDA says prior public participation will not be feasible or appropriate before it implements virus-related guidance documents. Notwithstanding the immediate issuance, FDA still will solicit comments, review
FDA Policy/General
Federal Register notice: FDA has postponed the 4/2-3 Blood Products Advisory Committee meeting due to the coronavirus public health emergency. To view the notice, click here.
Biologics
CBER director Peter Marks says that FDA and the European Medicines Agency jointly chaired a 3/18 meeting of global regulators to discuss regulatory strategies to facilitate the development of SARS-CoV-2 vaccines for use in the Covid-19 pandemic. An FDA statement says the meeting's purpose
Drugs
A 9/11-9/17/19 FDA inspection at Hangzhou Linkeweier Daily Chemicals Co., Ltd., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing regulations (CGMP) for finished pharmaceuticals. A 3/13 Warning Letter says specific violations were: * failing to conduct for each batch of drug product appropriate laboratory
Drugs
A 9/16-9/19/19 FDA inspection at DermaPharm A/S, Farup, Denmark, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate laboratory determination of satisfactory
Biologics
CBER says it is possible that convalescent plasma collected from recovered Covid-19 patients could contain antibodies to the SARS-CoV-2 virus and thus be effective against the infection. While clinical trials on such use are being pursued, the Center says in an online post that it is facilitating
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates that FDA used a new draft guidance on demonstrating substantial evidence of effectiveness for human drug and biological products to complement and expand on an existing 1998 guidance to address new, innovative drug development approaches. In a comment letter, the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hangzhou Linkeweier Daily Chemicals, Hangzhou, China (3/13) FDA inspected the firm 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to conduct
Drugs
FDA has released a final guidance entitled “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” The guidance was issued in response to a number of queries from entities that are not currently registered drug manufacturers that would
Devices
In a letter to medical device establishments, CDRH says it has taken some steps to prioritize work that advances the nation’s response during the Covid-19 national emergency. The letter says the steps “seek to address the impact of the Covid-19 public health emergency on day-to-day
Drugs
FDA says patients, caregivers, and healthcare professionals should be aware that EpiPen 3.0mg and EpiPen Jr 0.15mg and their authorized generic versions may potentially have delayed injection or be prevented from properly injecting. The agency notice says problems can be due to (1) device failure from spontaneous activation
Devices
To increase U.S. coronavirus supplies, FDA is now providing instructions to manufacturers importing personal protective equipment (PPE) and other devices. The instructions clarify the types of PPE that can be imported without agency interaction. It also includes advice on information importers can submit to expedite their import entries. “We
Drugs
FDA approved 3/23 orphan drug status for Gilead’s antiviral drug remdesivir, giving the company seven years of exclusivity for the product, which is one of many being tested as a possible Covid-19 treatment. The Intercept reports that experts say the designation could block supplies of the drug
Biologics
FDA has issued a safety alert telling healthcare providers and patients about the potential risk of transmitting the SARS-CoV-2 virus by using fecal microbiota for transplantation. FDA says that it has determined that additional safety protections are needed. The alert says that several recent studies have documented the
Devices
FDA has issued an emergency use authorization for Cepheid’s point-of-care coronavirus diagnostic, the Cepheid Xpert Xpress SARS-CoV-2 test, which can provide test results within hours instead of days current testing requires. The test is for use in high- and moderate-complexity CLIA-certified laboratories as
Drugs
FDA has given Genentech the green light to begin a randomized, double-blind, placebo-controlled Phase 3 clinical trial in collaboration with the Biomedical Advanced Research and Development Authority to evaluate the safety and efficacy of intravenous Actemra (tocilizumab) plus standard of care in hospitalized adult patients with severe coronavirus
Drugs
Eli Lilly says it is delaying most new study starts and pausing enrollment in most ongoing studies. For ongoing clinical trials where patients are already enrolled, Lilly says these will continue as planned. “The COVID-19 pandemic has substantially impacted the global healthcare delivery system, including the conduct of clinical
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Submission of Plans for Cigarette Packages and Cigarette Advertisements.” The document is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. To
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to its guidance entitled “Combination Products: How to Write a Pre-Request For Designation (RFD).” The document clarifies the type of information the agency’s Office of Combination Products (OCP) recommends that a sponsor include in a
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.” The document discusses the temporary compounding of such products by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities. To view
Drugs
After touting a drug last week (see story) as already approved for treating coronavirus, president Trump has doubled down in promoting the malaria drug chloroquine for immediate use. During a 3/19 White House press briefing, Trump confusingly said that chloroquine was approved and available for use. “Normally the FDA