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As the public comment period closes Monday on the FDA’s rule to regulate laboratory-developed tests (LDT), the FDA has received more than 2,100 remarks — including hundreds in opposition that are identical — that strongly diverge on whether the proposed rule will ensure test reliability or will burden labs with red tape and reduce the availability of tests for infectious diseases. Read More
Recalled glucose capsules marketed as a health supplement for blood glucose control were found to contain glyburide and metformin — drugs that treat type 2 diabetes by lowering blood sugar — were deemed a Class I recall by the FDA, the most serious type of recall as use may cause serious injuries or death. Read More
The FDA announced changes to the organizational structures of Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR) and the Office of Vaccines Research and Review (OVRR) intended to address the changing public health environment. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
In an expansion of its investigation into suicidal ideation associated with GLP-1 agonists, the European Medicines Agency (EMA) wants manufacturers to answer some undisclosed questions about these drugs, while the popularity of these drugs also continues to expand. Read More
Over the past week, the FDA issued proposed rules to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals and to require premarket approval applications for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance. Read More
Namandje Bumpus, currently chief scientist for the FDA, will replace Janet Woodcock as principal deputy commissioner, FDA Commissioner Robert Califf announced Wednesday. Read More
AbbVie and ImmunoGen today announced an agreement under which AbbVie will acquire ImmunoGen, and its flagship cancer therapy Elahere (mirvetuximab soravtansine-gynx) an antibody-drug conjugate (ADC) approved for platinum-resistant ovarian cancer, accelerating AbbVie’s presence in the solid tumor space. Read More
Kilitch Healthcare India received an FDA Form 483 citing lack of sterility, incomplete laboratory records and inadequate laboratory controls, inadequate validation of aseptic processes and unclean and insanitary buildings following an eight-day October inspection of its Mumbai, Maharashtra sterile drug manufacturing facility. Read More
Novo Nordisk has filed complaints against two Florida-based compounding pharmacies for marketing unapproved versions of its semaglutide products, claiming the products are weaker in strength than labeling indicates and may contain up to 33 percent impurities. Read More