Drugs
“Had FDA been enforcing the regulations … up to this point, the U.S. government could have imposed at least $45 billion in fines,” say three Johns Hopkins University students who are members of the Clinical Trials Transparency Committee of the Hopkins chapter of Universities Allied for Essential Medicines (UAEM). “However,
FDA Policy/General
FDA commissioner Robert Califf told a Senate appropriations hearing 4/19 that FDA and CMS are working to make sure clinical trials for products that are seeking accelerated approval are designed to address FDA approval requirements as well as include data to support a CMS ”reasonable and necessary” determination for
Drugs
DBV Technologies has received written responses from FDA after a pre-BLA meeting in February about the regulatory path for investigational Viaskin Peanut 250 μg patch (DBV712) for use in toddlers with a confirmed peanut allergy. The French biotech company says the agency granted its meeting request on a written
Drugs
BelGene says the results of the Phase 3 RATIONALE 305 trial of tislelizumab with chemotherapy met its primary endpoint of overall survival compared with chemotherapy alone in patients with advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, regardless of PD-L1 status. A company statement says no new safety
Drugs
A 10/10-10/14/22 FDA inspection at the Zermat International drug manufacturing facility in Tlalnepantla, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/6 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Devices
Fresenius Kabi has recalled its Ivenix Infusion System due to a leak in the device that allows fluid to enter the administration set loading area near the air detector. If such leaks occur, they could damage the electrical system, leading to loss of power and failure of the system’s
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Rapid Response Surveys” (OMB Control Number 0910-0500). The collection supports these surveys FDA conducts to determine whether a problem impacts the public health and to quickly obtain vital information about risks and interventions. Participation in the
FDA Policy/General
Federal Register notice: FDA is announcing it is revoking the emergency use authorizations (EUAs) issued to BioFire Defense for the FilmArray NGDS BT‐E Assay, and Biocartis for the Idylla Rapid Ebola Virus Triage Test. The companies said the Ebola tests are no longer commercially available and requested that their
Devices
A 6/14-6/23/22 FDA inspection at the North American Diagnostics medical device operations in Holly Hill, FL, found that the firm manufactures and distributes several unapproved Covid-19 tests. A just-released 12/27/22 Warning Letter says the company acknowledged that it had “improperly distributed into
Drugs
FDA has published a draft guidance, Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment, with information and recommendations to assist sponsors and other interested parties in developing drugs to prevent or treat acute radiation syndrome caused by exposure to ionizing radiation from accidental or deliberate events. The document is
Drugs
The National Cancer Institute (NCI) says Syndax Pharmaceuticals’ revumenib, a menin inhibitor, showed promise in an early-stage clinical trial for treating acute myeloid leukemia. An NCI statement says treatment with revumenib in the AUGMENT-101 trial caused about one-third of study participants’ cancers to completely disappear. The statement
Drugs
An FDA online statement says drug compounders should know their active pharmaceutical ingredient (API) and excipient suppliers and know if the suppliers are testing the components for purity and quality before they are purchased for use in compounding. The statement says that improper repackaging or lack of supply chain transparency
Drugs
A ProPublica report says FDA has been very slow to ramp up domestic and foreign drug manufacturer inspections following the Covid-19 pandemic. “Three years after the pandemic started, FDA has been slow to return to pre-pandemic inspection rates,” the analysis says. “The pandemic heightened the urgency surrounding FDA’
Drugs
Sidley attorneys say a 4/12 FDA final guidance, A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers, “reinforces the significant expectations for oversight by trial sponsors, the need for them to have a comprehensive quality risk management approach, and the particularly acute obligations for companies that
Drugs
GenBioPro, the generic drug maker of abortion drug mifepristone, filed a 4/19 lawsuit against FDA in Maryland federal court to block the agency from taking any actions against the company if a pending court order under review by the U.S. Supreme Court requires the drug to be restricted
Drugs
FDA has approved a new indication for AbbVie’s Qulipta (atogepant) to include the preventive treatment of migraine in adults. A company statement says Qulipta is the only oral calcitonin gene-related peptide receptor antagonist approved to prevent episodic and chronic migraine. The expanded indication was based on the Phase
FDA Policy/General
The U.S. Supreme Court 4/19 extended by two days its administrative stay of a lower court’s 4/7 order (see earlier story) that would restrict the distribution of the abortion drug mifepristone. The additional stay until 11:59 PM 4/21 gives the high court additional time
Drugs
An ongoing European Medicines Agency (EMA) and FDA joint initiative on information sharing involving generic drug bioequivalence study inspections has just grown by one more EU Member state — Ireland. The countries now participating in the FDA/EMA information sharing pact are: Austria, France, Germany, Ireland, Italy, The Netherlands, Spain, and
FDA Policy/General
FDA has granted traditional approval to Genentech’s Polivy (polatuzumab vedotin-piiq) for combination use with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for treating certain adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL). Previously the drug was available under accelerated approval in combination with
Biologics
FDA has amended the emergency use authorizations for the Moderna and Pfizer/BioNTech Covid-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals and permit a second booster for certain at-risk populations. An agency notice lists these key changes: * most individuals, depending on age, previously vaccinated
Drugs
Two CDER Office of Orphan Products Development researchers say lessons learned from rare disease product development during the Covid-19 pandemic can be applied to future trials in rare diseases. Writing in Contemporary Clinical Trials, the authors say the two important lessons were: * virtual capabilities, when appropriate, can be an
Drugs
The CDER Office of New Drugs (OND) Regulatory Research Program, which was started in 2018 to centralize and create an infrastructure for OND regulatory science research, recently published its first two fiscal year annual reports. Research Program associate director Laura Jaeger says in an online post the reports “are a