Drugs
FDA says it is requiring that labeling for opioid pain medicines and medicine used to treat opioid use disorder be updated to recommend that healthcare professionals routinely discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment. An agency drug safety communication says healthcare professionals
Drugs
Fresenius Kabi has recalled two lots of dexmedetomidine HCl in 0.9% sodium chloride injection due to the possibility of a trace amount of lidocaine present in the two lots. The drug is approved for intravenous use and indicated for sedation of non-intubated patients prior to or during surgical
Drugs
Three FDA Centers and the Federal Trade Commission say that Web sites and YouTube channels operated by Create Wellness Clinics (21st Century LaserMed Pain Institute), Garden Grove, CA, are offering products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in
Drugs
An unnamed client represented by Lassman Law & Policy is asking FDA not to issue a BLA to Mesoblast for its Ryoncil (remestemcel-L) (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion) to treat pediatric patients with steroid-refractory acute graft-versus-host disease (aGVHD)
Drugs
The CDER Biomarker Qualification Program has responded positively to a C-Path Predictive Safety Testing Consortium/Duchenne Regulatory Science Consortium qualification plan for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury. A C-Path statement says the two consortia “provided scientific evidence supporting the use of
Drugs
A bipartisan group of 18 members of Congress is asking FDA to provide information on its “policies mandating that drug companies conduct testing on dogs to fulfill regulatory requirements.” Their 7/22 letter says the “lawmakers understand from recent reports that in these tests dogs, even small puppies, are made
Drugs
The FDA Oncology Center of Excellence (OCE) says that people with cancer are at an increased risk of more serious outcomes from Covid-19. In data analyzed with Synapse, OCE also found that there are inequities for Black Americans and those of lower socioeconomic means. “It’s imperative that we
Drugs
FDA is evaluating several different tests that can simultaneously test for both the flu and Covid-19 as part of the preparation for fall and winter when the U.S. will likely face both, FDA commissioner Stephen Hahn told Fox Business 7/22. He said the combination tests will help
Drugs
A 10/3-10/25/19 FDA inspection at Stason Pharmaceuticals, Irvine, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/8 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
A 12/16-12/20/19 FDA inspection at the Signa SA de CV facility in Toluca De Lerdo, Mexico, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 7/14 Warning Letter says the specific violation was failing to adequately investigate out-of-
Drugs
FDA says Centurion Medical Products, Williamston, MI, manufactures and distributes sterile convenience kits that have not been approved or cleared by FDA. A just-released 6/11 Warning Letter says the agency’s 8/5-8/20/19 and 11/21-11/1/19 inspections at two Centurion sites determined
Drugs
FDA has placed a Pieris Pharmaceuticals Phase 1 study of PRS-343 on partial clinical hold while the company conducts an additional in-use and compatibility study requested by the agency. Currently-enrolled patients may continue to receive treatment, the company says, but no new patients can be enrolled until
Drugs
FDA has published a draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, outlining the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. The document does not address the development of fully
Drugs
FDA issued 7/9 a second Funding Opportunity Announcement (FOA) as part of the agency’s Standard Core COAs and Endpoints Pilot Grant Program. CDER director of patient-focused drug development and program offer for the FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoint Pilot Grant Program Robyn Bent
Drugs
FDA is extending by six months its enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) due to the Covid-19 public health emergency. The extension will provide manufacturers and potential sponsors an additional six months to determine if they need to submit
Drugs
FDA says it is currently reviewing its internal laboratory safety program to align with ongoing, shifting, and future priorities. As part of the safety program, the agency’s Office of Laboratory Safety (OLS) has also “initiated a collaborative effort to adopt and standardize a laboratory safety audit and inspection process
Drugs
FDA has accepted for review an Acadia Pharmaceuticals supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with dementia-related psychosis. The agency has assigned a standard review with a user fee review action date of 4/2/2021. The sNDA is based on data from a the
Drugs
Pfizer and BioNTech have announced positive data from an ongoing German Phase 1/2 trial involving its mRNA-based BNT162 coronavirus vaccine program. The data are available on an online preprint server at medrxiv. The data demonstrated the ability of BNT162 to elicit high SARS-CoV-2 neutralizing titers, the
Drugs
AstraZenca is reporting positive interim data from an the ongoing Phase 1-2 COV001 trial, which showed that its AZD1222 vaccine was tolerated and generated “robust immune responses against the SARS-CoV-2 virus in all evaluated participants.” Led by Oxford University, the trial involves 1,077 healthy adult participants
Drugs
FDA has sent a Warning Letter to the operators of www.pharmaboosters.com over marketing unapproved and misbranded drugs for preventing Covid-19 and a variety of other diseases such as major depressive and anxiety disorders. For example, FDA says the Web site offers Arbidol for sale and states that
Drugs
FDA has granted Denovo Biopharma a fast track designation for DB102 (enzastaurin) and its use as a potential treatment for patients with newly-diagnosed glioblastoma. Enzastaurin is a serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients
Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says that with the planned FDA resumption of domestic inspections, there are three likely scenarios involving the still-paused foreign inspections. Writing in his firm’s FDA Law Blog, Schwartz says that either on-site foreign inspections will resume, FDA will loosen an