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CBER is asking biologics manufacturers to allow the center’s regulatory review, compliance and other relevant staff to visit facilities to help them better understand the biologics industry. Read More
Several major drugmakers are exploring development of a vaccine to prevent the Zika virus as the mosquito-borne disease spreads quickly throughout the Western Hemisphere. Read More
One week after accusing Gilead Sciences of promoting an HIV drug off-label, an AIDS nonprofit is suing the company for allegedly “manipulating the patent system” to ward off generic competition for another medication. Read More
Eleven healthcare groups — including the Generic Pharmaceutical Association — are asking a Senate committee to examine alleged industry abuse of REMS safeguards as a possible cause of rising drug prices. Read More
Drugmakers interested in establishing bioequivalence for their products have a treasure trove of data to dig through, as the FDA has just added 35 new product-specific guidances and updated 12 more. Read More
The FDA is not in the business of regulating drug prices, CDER Director Janet Woodcock told a Senate committee Jan. 28, pushing back against criticism that the FDA should tackle rising drug prices. Read More
In his fiscal year 2017 budget, President Barack Obama says he will seek more than $1 billion in mandatory funding over two years to help combat prescription opioid abuse. Read More
Two Oregon supplement makers are in the FDA’s crosshairs for marketing their products for a range of unapproved conditions, including regulating blood pressure and alleviating panic attacks. Read More
In a rare warning letter to an institutional review board, CDER’s Office of Scientific Investigations contends that an IRB at Monmouth Medical Center was lax in supervising research at the facility. Read More
Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More