The U.S. Food and Drug Administration has released the following news item:
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.
Sterility concerns have prompted Abrams Royal Pharmacy to voluntarily recall all unexpired lots of sterile products dispensed nationwide, including injectable medications, IVs, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments, FDA reported on its Web site.
In an effort to lessen the impact drug shortages have on public health, FDA has published a strategic plan to improve the agency’s response to imminent or existing shortages and to develop longer-term approaches for addressing the underlying causes of such shortages, the agency reported on its Web site.
FDA has finalized its Unique Device Identification (UDI) regulation intended to drive consistency in medical device identification. The final rule requires that most medical devices distributed in the United States bear a unique device identifier, the agency posted on its UDI page today.
Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Karbinal™ ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.
Merck, known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT.