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As the FDA moves to update and standardize data submission standards for NDAs, ANDAs, INDs and BLAs, it’s warning sponsors they will only have two years to come into compliance once guidance is finalized later this year. Read More
In an effort to build opposition to the FDA’s proposed generic drug safety labeling rule, GPhA is warning that spending on generics will rise by $4 billion per year if the rule is finalized. Read More
The FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
The FTC Tuesday said regulations and legislation governing the naming and dispensation of biosimilars should match those already in place for generic drugs to avoid chilling competition among drugmakers. Read More
Following the FDA’s lead, the Scottish Medicines Consortium (SMC) said Monday it plans to launch a new initiative on patient-centered research, giving patient groups and clinicians a stronger voice in how drugs for life-threatening and rare diseases are developed and approved. Read More
Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
PhRMA placed itself in the middle of a mounting battle over biosimilar naming Monday, calling on the FDA to deny GPhA’s petition for same-name biosimilars and arguing that distinguishable, yet related names are “essential” for adverse event reporting. Read More
CDER plans to issue highly anticipated guidance in 2014 that addresses social media usage for pharma marketing and the specifics about its biosimilars approval pathway. Read More