A Chinese drugmaker was storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes,…
DexCom’s G7 prescription continuous glucose monitoring (CGM) system now connects directly to Apple Watch for users in the US, making it the first to offer real-time glucose readings so that…
CDER plans to refuse to approve a supplemental new drug application (sNDA) for Vanda Pharmaceuticals’ Hetlioz (tasimelteon), in the latest of a back and forth battle over the drug dating…
Generic sterile injectables — such as antibiotics, anesthetics and vaccinations — faced a 91 percent risk of being in short supply in 2023 and 58 percent of injectable drugs went…
The Association for Accessible Medicines (AAM) Biosimilars Council’s recent white paper recommends the FDA streamline its regulation of biosimilar development to allow more affordable biologics products to the market more…
Two devicemakers in Mississauga, Ontario — Techlem Medical and Trexo Robotics Holdings — received recently released FDA Warning Letters with Techlem cited for quality issues and Trexo for marketing unapproved…
Members of the FDA’s Psychopharmacological Drugs Advisory Committee voted strongly against recommending MDMA, also known as “ecstasy,” as a potential treatment for post-traumatic stress disorder (PTSD) at their meeting on…
The 340B Drug Discount Program needs more regulation, oversight and transparency to combat abuse by bad actors, according to members of the House Energy and Commerce Committee’s Oversight and Investigations…
Inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva found on employee clothing are among the litany of observations from an FDA Form 483 levied on Shanghai-based…
The FDA has released two draft guidances on how sponsors can prepare for bioresearch monitoring inspections (BIMO) in both their marketing applications as well as prior to and during the…