Drugs
The American Geriatrics Society (AGS) says FDA should consistently use the word “older” in a draft guidance on geriatric information in human prescription drug and biological product labeling rather than “elderly” or any similar term. In an 11/9 comment letter, AGS says that terms like “elderly,” “elders,” “the aged,
Devices
FDA says its review of data and information from several sources indicates that there generally are more benefits than risks to patient safety and health related to software functions excluded by the 21st Century Cures Act from the definition of a medical device. The agency’s 2020 report on risks
Drugs
FDA has accepted for review a BLA submitted by Samsung Bioepis and Biogen for their SB11, a proposed biosimilar referencing Genentech’s Lucentis (ranibizumab). Lucentis is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders. Samsung Bioepsis said in 11/2019 that it had entered into a
Biologics
Omeros has completed a rolling BLA submission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The monoclonal antibody targets mannan-binding lectin-associated serine protease-2 (MASP-2), the company says. “Importantly,” it says, “inhibition of MASP-2 does not appear to interfere with the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Electromagnetic Compatibility of Medical Devices. The document describes relevant information that should be provided in device premarket submissions. To view the notice, click here.
Drugs
CDER researchers say they have determined that adding a cyclin-dependent kinase (CDK) 4/6 inhibitor to a hormonal agent appears to show a consistent benefit for all subgroups analyzed in a study of hormone receptor-positive, HER2-negative metastatic breast cancer. An agency online Regulatory Science Impact Story says
Drugs
FDA has announced a 1/26 virtual workshop to communicate current regulatory thinking and considerations on non-clinical assays for comparative immunogenicity risk assessment for generic peptide products. The agency says the workshop will discuss the following four topics: * In silico methods to assess binding affinity to major histocompatibility complex
Drugs
FDA commissioner Stephen Hahn says that the agency is increasing transparency for Covid-19 emergency use authorizations (EUAs) by posting CDER and CBER reviews of the scientific data and information supporting the issuance, revision, or revocation of EUAs for all drug and biological products, including vaccines. Such a move was
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) has added a new chapter, “Enhancing Diversity in Clinical Trial Participation,” to its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. A PhRMA statement says the revised principles take effect 4/14/21. With the revision, the statement says,
Drugs
FDA has posted safety-related labeling changes for five biologics. The change for Merck’s Keytruda (pembrolizumab) involves the potential for infusion reactions added to the Warning and Precautions section of the labeling. Changes were also posted for EMD Serono/Pfizer’s Bevencio (avelumab), Lilly’s Erbitux (cetuximab), AstraZeneca’s
Drugs
A 2/3-2/12 FDA inspection at Family Pharmacy of Statesville, Statesville, NC, found multiple drug compounding violations. An 11/6 Warning Letter discusses violations relating to compounded drug products under the Federal Food, Drug, and Cosmetics Act, failing to meet the conditions of Section 503A, adulterated drug products,
Drugs
FDA has issued a final guidance on Certificates of Confidentiality, which describes the agency’s implementation of revised provisions under the 21st Century Cures Act (Cures Act). A Certificate of Confidentiality (CoC) is intended to help protect the privacy of human subject research participants when identifiable, sensitive information is being
Drugs
FDA has issued a complete response letter (CRL) for the Alkermes NDA for its ALKS 3831 (olanzapine/samidorphan) for treating adults with schizophrenia and bipolar 1 disorder. The letter indicates that FDA requires the resolution of certain conditions related to the tablet coating process at the firm’s Wilmington, OH,
Drugs
FDA meetings with industry on product development issues are suffering from fewer interactions and participation due to Covid-19 and the necessary move to virtual presentations and discussions, CDER deputy Center director for clinical science Bob Temple told the virtual Prevision Policy/Friends of Cancer Research Biopharma Congress last month.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Family Pharmacy, Statesville, NC (11/6): FDA inspected the firm 2/3-2/12 and cited multiple drug compounding and GMP violations. For example, it failed to establish an
Devices
Federal Register notice: FDA has made available a draft guidance entitled Electromagnetic Compatibility of Medical Devices. The document describes relevant information that should be provided in device premarket submissions. To view the notice, click here.
Drugs
An 11/19 Biosimilar User Fee Act (BsUFA) reauthorization public meeting is likely to hear proposals for potential enhancements or efficiencies for the biosimilar product development and review process. That’s an expectation voiced by CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim in a CDER Conversation. She
Devices
A 10/22 CDRH Webinar provided background information and an overview of the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. In the presentation, CDRH Standards and Conformity Assessment Program senior policy analyst Stacy Cho said that during the MDUFA 4 reauthorization negotiations, FDA and industry agreed to establish a
Drugs
Representatives Brendan Boyle (D-PA), Scott Perry (R-PA) and Madeleine Dean (D-PA) have introduced the Alternatives to Animals for Regulatory Fairness (AARF) Act to modernize the drug approval process. “The AARF Act ensures that pharmaceutical companies are allowed to use high-tech and humane alternatives to outdated testing
Drugs
Moderna says its investigational Covid-19 vaccine is showing a 94.5% efficacy rate based on a NIH-appointed data safety monitoring board interim analysis. The COVE study, which enrolled more than 30,000 participants to evaluate the company’s messenger RNA vaccine (mRNA-1273) has reached 95 Covid-19
FDA Policy/General
FDA commissioner Stephen Hahn says that over the past year the agency has seen about 1,000 net growth in staff due to a streamlined hiring spree authorized by the recent CURES Act. “For FY 20, the FDA hired 2,308 staff (and lost 1,281) with a total net
Drugs
FDA has issued Adamis Pharmaceuticals another complete response letter (CRL) on its NDA for Zimhi, a high-dose naloxone injection product for treating opioid overdose. The letter provided recommendations to support the NDA’s resubmission. “The questions raised by the FDA related generally to new chemistry, manufacturing and controls issues,