The latest headlines across every section, pulled from official and open-access sources.
Due to packaging discrepancy with incorrect product size mixed up. — Encore Medical, LP · Class II · Ongoing · 8
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process. — Medline Industries, LP · Class II · Ongoing · 75 kits
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used. — Integra LifeSciences Corp. (NeuroSciences) · Class II · Ongoing · 633 units
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 120 units
undeclared soy — Bear Stewart Co · Class II · Ongoing · 313 cases
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 81 units
The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3. — Wise Foods Inc · Class II · Ongoing · 490 cases
Potential contamination with Salmonella — Trafa Pharmaceutical Inc. · Class I · Ongoing · 500 kg
Undeclared Allergen (Soy) — Specialty Bakers, LLC · Class II · Ongoing · 449 cases
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 32 units
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella. — Fresh & Ready Foods LLC · Class I · Ongoing · 377 units
Foreign material: small metal pieces — Wondermade LLC · Class II · Ongoing · 154 boxes
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class I · Ongoing · 20 units
Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging. — Lehi Valley Trading Company, Inc · Class I · Ongoing · 624 plastic 15oz tubs: 585 lbs total
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella. — Fresh & Ready Foods LLC · Class I · Ongoing · 216 units
Undeclared Sesame allergen — Adams Extract & Spice LLC · Class II · Ongoing · N/A
Guidance on transitional arrangements for the Clinical Trials Regulations.
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation.
This plan sets out how the Department of Health and Social Care plans to improve the use of BSL in its communications in the next 5 years. Includes an annual progress update.
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
Less than a month after locking down a lease for a new U.S. headquarters, radiotherapy outfit AdvanCell is poised to push its lead prostate cancer candidate into phase 3 development with the help of a $315 million series D.
EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today…, Enabling innovation is central to our public health mission to bring new treatments to patients. Our collaboration with EISMEA helps us better support innovators to…, The earlier health innovators can engage with regulatory expertise, the better equipped they are to make informed development decisions, reduce risk and achieve our…, EMA and EISMEA will continue to work together on horizon scanning and regulatory…
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Families across the country are being encouraged to help children stay active over the summer holidays.