Sentences with phrase «required pharmaceutical manufacturers»
The FDA in the past has not required pharmaceutical manufacturers to prove the elixirs, which have been sold for decades, work in children, allowing dosing to be gleaned from adult data.
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Tracking technology in the form of barcodes or RFID chips can establish a data trail that allows companies to follow each lot from manufacturer to pharmacy shelf, and as of 2013, tracking of pharmaceuticals throughout the supply chain is required as per the Drug Quality and Security Act.
The TPP requires parties to provide a «pre-approval» procedure for patented pharmaceuticals, with two options: 1) provide notice to a patent holder if a competitor applies to market an identical or similar drug during the patent term, along with an opportunity to seek a legal remedy such as a preliminary injunction before the generic drug is marketed; or 2) preclude marketing approval for a drug that is subject to another person's patent, unless the patent holder or original drug manufacturer consents.
Although this may constitute negligence, the defective product claims and pharmaceutical liability laws that govern defective drug cases do not require plaintiffs to show that the manufacturers and / or distributors of these drugs acted negligently.