Biologics
During a 7/30 NewsNation interview, FDA commissioner Martin Makary promoted a popular right-wing conspiracy theory by saying that under its former leadership, the National Institutes of Health (NIH) funded the lab that created the Covid-19 virus. The Hill reports that Makary made the comment in response to
Drugs
FDA has released the form FDA-483 issued following a 6/3-6/14/2024 inspection at the Jubilant HollistierStier General Partnership drug manufacturing facility in Kirkland, Province Quebec, Canada. The 15 inspection observations were: * failure of the statistical quality control criteria to include appropriate acceptance and rejection levels; * failure
Devices
FDA has cleared a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals. These signals are intended to offer clinicians a more complete picture of heart function, including insights into cardiac mechanics, blood flow, and hemodynamics, according
Drugs
FDA says the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program has transitioned to a permanent drug development tool (DDT) qualification program. An FDA Voices post, written by CDER Office of Translational Sciences director ShaAvhrée Buckman-Garner and Office of New Drugs acting director Mary Thanh Hai,
Biologics
Based on conversations with four anonymous knowledgeable sources, Politico is reporting that President Donald Trump overruled FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., to insist that CBER director Vinay Prasad be removed from FDA. Prasad had come under attack from conservative presidential whisperer Laura Loomer, former
Drugs
U.S. senators Ted Budd (R-NC) and Martin Heinrich (D-NM) have introduced a bipartisan amendment to FDA’s spending bill to strengthen the agency’s ability to prevent illicit pharmaceuticals and active pharmaceutical ingredients from entering the U.S., particularly from unregistered manufacturing facilities in China. “These illicit
Drugs
In a significant move aimed at curbing long-term misuse of opioid drugs, FDA is announcing new mandatory safety labeling changes for all opioid analgesics. The changes are designed to highlight the serious risks of prolonged use — including addiction, overdose, and death — and are based on new data and a
Devices
FDA has published a guidance, Medical Device User Fee Small Business Qualification and Determination, describing the process for how a business may request a determination that it qualifies as a small business for the purpose MDUFA provisions about reduced fees for such businesses. The document says that a business that
Drugs
FDA has granted Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma. The company describes the drug as a first-in-class inhibitor targeting the Hippo signaling pathway, a key regulator of cell growth and organ size. Specifically, the drug is designed to block autopalmitoylation
FDA Policy/General
Top House Democrats on the Energy and Commerce Committee are raising concerns over what they describe as a coordinated effort by the Trump Administration to restrict access to vaccines and undermine public trust in the nation’s immunization system. Two oversight letters sent to FDA commissioner Marty Makary and HHS
Drugs
FDA says it is aware that some patients and healthcare professionals may look to unapproved GLP-1 drugs (including semaglutide and tirzepatide) as an option for weight loss. “This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness, and quality before they
Drugs
AbbVie has submitted a supplemental NDA seeking approval for a new, fixed-duration, all-oral combination regimen of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukemia (CLL). The submission is based on data from the Phase 3 AMPLIFY trial, which showed that the venetoclax-acalabrutinib combination
Drugs
FDA says it terminated its Arthritis Advisory Committee as of 7/30. A Federal Register notice says the committee was established on 4/5/1974 to advise on drugs and other regulated products for human use in arthritic conditions. “The committee has met infrequently in recent years,” the notice says,
FDA Policy/General
FDA commissioner Martin Makary says that while he wants to speed patients’ access to needed drugs, he also wants to reduce the need for pharmaceuticals by addressing the root causes of diseases. In an interview with Yahoo Finance, Makary said he has been focused on ensuring quicker access to drugs,
Biologics
[Analysis by Jim Dickinson and David McFarland] As FDA reels and staff morale plummets under anti-science political interference from the Trump Administration, newly appointed CBER director Vinay Prasad has abruptly departed the agency after being attacked by Trump influencer Laura Loomer for expressing purportedly left-wing political views as
Biologics
FDA has granted Calidi Biotherapeutics fast-track status for CLD-201, an allogeneic stem-cell-loaded oncolytic virus being developed to treat soft tissue sarcoma. The therapy uses adipose-derived mesenchymal stem cells loaded with an oncolytic vaccinia virus to deliver therapy directly to tumor sites, according to the company.
Devices
A 2/4-4/4 FDA inspection at Onkos Surgical in Parsippany, NJ, determined that the firm is a specification developer of the ELEOS Limb Salvage System, indicated for use in total knee and hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature
Drugs
A 9/2-9/6/2024 FDA inspection at the Macsen Drug manufacturing facility in Tehsil Mavli, Udaipur, Rajastahn, India, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 3/25 Warning Letter says the specific violations were: * failure of the
Biologics
Johnson & Johnson has submitted a supplemental BLA seeking to update the prescribing information for Tremfya (guselkumab) to include new data demonstrating its ability to inhibit structural joint damage in adults with active psoriatic arthritis (PsA). The submission is based on 24-week results from the Phase 3b APEX placebo
Drugs
FDA is recommending placing 7-hydroxymitragynine (7-OH) —a highly concentrated, synthetic byproduct of the kratom plant — under the Controlled Substances Act. The move marks a strategic crackdown on products the agency says are potent, addictive, and increasingly available in unregulated forms. Unlike natural kratom leaf, which is not currently
Drugs
A 1/20-1/24 FDA inspection at the Shiva Analyticals Private Limited contract testing laboratory in Hoskote, Bangaluru, Karnataka, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/23 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained
Drugs
The CDER Office of Pharmaceutical Quality has published a white paper, “Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective,” that concludes the costs of investing in quality management initiatives are outweighed by the far-reaching economic and societal benefits. The paper says the growing momentum toward mature quality