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Medline Issues Class I Correction for Convenience Kits Containing Recalled B. Braun Bupivacaine Hydrochloride Components

Medline Issues Class I Correction for Convenience Kits Containing Recalled B. Braun Bupivacaine Hydrochloride Components

Medline has issued a Class I recall, the FDA's most serious classification, for several of its convenience kits that contain B. Braun Bupivacaine Hydrochloride in Dextrose Injection, USP. This recall is a 'correction' rather than a removal, meaning affected devices are not being removed from use but require modification. The issue stems from a prior recall initiated by Huons Co., Ltd. for its Bupivacaine HCL in Dextrose Injection, USP, due to potential contamination. Medline's kits, which include products like Anterior Hip Kits, C-Section kits, and various Total Knee Kits, are used for pain management and regional anesthesia. Risks associated with compromised injectables include infection, inflammatory response, reduced anesthetic effectiveness, and, if used neuraxially, cerebral fluid contamination and meningitis. As of April 24, B. Braun reported 35 serious injuries with no deaths related to this issue, while Medline has reported no additional serious injuries or deaths as of June 19.
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U.S. Lawmakers Urge FDA to Tighten Regulations on Chinese Clinical Trial Data Following Patient Deaths

U.S. Lawmakers Urge FDA to Tighten Regulations on Chinese Clinical Trial Data Following Patient Deaths

Two Republican U.S. Representatives, John Moolenaar of Michigan and Ben Cline of Virginia, have sent a letter to the acting commissioner of the U.S. Food and Drug Administration (FDA), Kyle Diamantas, demanding stricter regulations on the use of Chinese clinical trial data in U.S. drug development and approval processes. This demand follows recent reports of three patient deaths in China involving experimental gene therapies, including two children. The lawmakers highlighted concerns that the U.S. is accepting unverified Chinese clinical data, potentially exposing patients to undue risks. They specifically requested that the FDA not accept clinical trial data generated in China for Investigational New Drug (IND) applications, New Drug Applications (NDA), or Biologics License Applications (BLA), unless the trial sites have undergone an FDA on-site inspection within 12 months prior to the application submission. Additionally, they called for a comprehensive evaluation of the U.S. reliance on Chinese-initiate...
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Congressman Morgan Griffith Proposes Bill to Limit THC in Edible Products

Congressman Morgan Griffith Proposes Bill to Limit THC in Edible Products

Congressman Morgan Griffith, a Republican representing Virginia's 9th District, is advocating for a bill to regulate the amount of THC in products such as gummies and soft drinks. Griffith stated that there are currently no restrictions on the THC content in these items, describing the situation as a 'wild west.' His proposed bill aims to set a limit of five milligrams of THC per product and would require the Food and Drug Administration (FDA) to conduct a study to determine if this limit should be adjusted based on scientific evidence. He noted that some states currently allow up to 100 milligrams of THC in drinks, which he considers excessive, while most states range between 2.5 and 10 milligrams.
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Nuvation Bio Receives FDA Fast Track Designation for Safusidenib in IDH1-Mutant Glioma Treatment

Nuvation Bio Receives FDA Fast Track Designation for Safusidenib in IDH1-Mutant Glioma Treatment

Nuvation Bio Inc., a global oncology company, has announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for safusidenib. Safusidenib is an investigational, oral, brain-penetrant selective inhibitor of mutant IDH1, intended for the treatment of IDH1-mutant glioma. This designation aims to accelerate the development and review process for drugs addressing serious conditions with unmet medical needs. The decision was based on favorable data from the safusidenib clinical program, including updated Phase 2 J201 study results. These results demonstrated durable responses and a positive risk-benefit profile over a median follow-up of 38.8 months, with a confirmed objective response rate (cORR) of 51.9% and a 36-month progression-free survival (PFS) rate of 79.1%. The company's pivotal Phase 3 SIGMA study is currently enrolling patients to further evaluate safusidenib.
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US health agencies report 55 cases of E. coli and salmonella infections tied to alfalfa sprouts

US health agencies report 55 cases of E. coli and salmonella infections tied to alfalfa sprouts

Aug 21 (Reuters) - U.S. health officials on Friday said they were investigating a multistate outbreak of E. coli and salmonella infections linked to alfalfa sprouts.
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Senator Cassidy Criticizes President Trump's FDA Nominee Dr. Heidi Overton Over Vaccine Order Involvement

Senator Cassidy Criticizes President Trump's FDA Nominee Dr. Heidi Overton Over Vaccine Order Involvement

Senator Bill Cassidy (R-La.), Chairman of the Senate Health Committee, has voiced strong concerns regarding President Trump's nomination of Dr. Heidi Overton to lead the Food and Drug Administration (FDA). Senator Cassidy, a physician, stated that Dr. Overton's involvement in the administration's recent executive order to reduce and separate childhood vaccine schedules is "almost disqualifying." He criticized her lack of managerial experience, suggesting it makes her ill-prepared to lead a large organization like the FDA, which is currently facing staffing and morale issues. Dr. Overton supports Health and Human Services Secretary Robert F. Kennedy Jr.'s 'Make America Healthy Again' movement and was present when President Trump signed the vaccine executive order on August 10. President Trump announced his intention to nominate Dr. Overton via a Truth Social post, three months after his first FDA commissioner, Marty Makary, resigned. Before her current role as a top White House domestic policy adviser on he...
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Prestige Brand Holdings Recalls 40,000 Bottles of Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns

Prestige Brand Holdings Recalls 40,000 Bottles of Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns

Prestige Brand Holdings has voluntarily recalled nearly 40,000 bottles of its Clear Eyes Maximum Itchy Eye Relief eye drops nationwide, including in Rhode Island. The U.S. Food and Drug Administration (FDA) reported that the recall is due to a "lack of assurance of sterility." The affected products are 15mL bottles with an expiration date of September 30, 2027. The FDA has classified this as a Class II recall, indicating that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Consumers are advised not to use the recalled eye drops as they could be contaminated or cause infection. Prestige Brand Holdings, a consumer healthcare company known for products like Dramamine and Breathe Right, has not yet responded to requests for comment.
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FDA Authorizes Emergency Drug for New World Screwworm Treatment in Dogs Amid U.S. Spread Concerns

FDA Authorizes Emergency Drug for New World Screwworm Treatment in Dogs Amid U.S. Spread Concerns

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Simparica Trio, a monthly chewable medication, to treat New World screwworm infestations in dogs and puppies. This authorization, granted on August 13, comes as federal officials are preparing for the potential spread of the parasitic fly in the United States. Simparica Trio, manufactured by Zoetis, was already FDA-approved in 2020 for heartworm disease, fleas, and ticks. Its active ingredient, sarolaner, an isoxazoline-class antiparasitic, is particularly relevant for screwworm treatment. The FDA's decision is based on scientific evidence suggesting the drug's effectiveness against New World screwworm myiasis, with benefits outweighing risks. However, the medication is not authorized for prevention and does not replace other critical aspects of treatment, such as larvae removal and wound management. The authorization follows the detection of 46 animal cases of New World screwworm in Texas and New Mexico, with t...
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President Trump Nominates Heidi Overton to Lead FDA Amidst Abortion Policy Shift Concerns

President Trump Nominates Heidi Overton to Lead FDA Amidst Abortion Policy Shift Concerns

President Trump has nominated Heidi Overton, a prominent health policy official and conservative activist, to head the Food and Drug Administration (FDA). Overton previously served at the America First Policy Institute, where she was an outspoken critic of abortion, particularly abortion medications. Her past statements include advocating for policies that prioritize 'greater protection for the two lives involved—the mother and the baby—especially with safeguards to protect women and children from the dangers of teleabortion.' She also celebrated the overturning of Roe v. Wade. This nomination comes as the Trump administration has faced pressure to address abortion policy, with conservatives expressing frustration over the FDA's previous handling of abortion drugs like mifepristone. The nomination is seen as a potential move to influence the FDA's stance on abortion-related issues, particularly following a review of mifepristone that was initiated after the previous FDA head, Marty Makary, was replaced.
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B. Braun Medical Inc. Recalls Excel® Lactated Ringers Injection Due to Particulate Matter

B. Braun Medical Inc. Recalls Excel® Lactated Ringers Injection Due to Particulate Matter

B. Braun Medical Inc. has initiated a voluntary North American recall of one lot of its Excel® Lactated Ringers Injection, 1000mL, distributed to hospitals and healthcare facilities. The recall is due to the presence of particulate matter in the solution, primarily identified as cellulose cotton fibers, with some particles also being cellulose wood fiber and polystyrene. The affected product, with lot number J4H077 and an expiration date of November 30, 2026, was distributed nationwide in the U.S. and to Canada between August 29, 2024, and September 30, 2024. The product is used for hydration and fluid replacement in adult, pediatric, and neonatal patients. B. Braun has not received any reports of adverse events related to this recall to date. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
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Cell Biotech's Duolac Probiotics Achieve Global Reach with Entry into South Africa, Securing FDA GRAS Status for Strains

Cell Biotech's Duolac Probiotics Achieve Global Reach with Entry into South Africa, Securing FDA GRAS Status for Strains

Cell Biotech's Duolac Probiotics Achieve Global Reach with Entry into South Africa, Securing FDA GRAS Status for Strains
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Cultivated Meat Industry Faces Significant Challenges Despite Early Hype and Investment

Cultivated Meat Industry Faces Significant Challenges Despite Early Hype and Investment

Cultivated Meat Industry Faces Significant Challenges Despite Early Hype and Investment