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The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes immediately. Read More
The 21st Century Cures Act represents a “missed opportunity” to clarify the distinction between a drug and a device and improve transparency, according to experts at a June 8 conference sponsored by FDAnews in Washington D.C. Thursday on combination products. Read More
The PTO’s Patent Trial and Appeal Board invalidated several claims relating to the manufacture of the widely used anesthetic Diprivan (propofol), in a patent held by Fresenius Kabi. Read More
FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure in mid-May, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers and ultimately moving to what may seem like stricter inspections, especially at first. Read More
The FDA sent a warning letter to Ranier’s Compounding Laboratory, based in Jeannette, Pa., noting serious deficiencies in sterile procedures and GMPs. Read More
A pharmacy chain operator that brought antitrust class action lawsuits against more than a dozen generics manufacturers earlier this week has added three more — Actavis Holdco, Lannett and Epic Pharma — claiming they colluded to raise the prices of the gallbladder stone treatment ursodiol. Read More
The Association of the British Pharmaceutical Industry will run advertisements later this month in three medical journals listing Astellas UK and Gedeon Richter as in breach of the ABPI’s Code of Practice, through the association’s Prescription Medicines Code of Practice Authority. Read More