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An FDA advisory committee narrowly voted against recommending an additional nerve block indication for Pacira’s Exparel, a local analgesic approved in 2011 for post-surgical pain management. Read More
In Jan. 30 testimony before a House subcommittee, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s level of risk. Read More
The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially for drugs like Vicodin and Percocet usually intended for short-term use. Read More
The FDA’s Office of Prescription Drug Promotion issued just three warning letters and one untitled letter in calendar year 2017 — a record low and down from a high of 156 in 1998. Read More
The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling. Read More
Medtech petitioned the FDA to allow the company to submit an ANDA for generic Excedrin in which the proposed product is in a dosage form different from the reference drug. Read More
In his first appearance as HHS Secretary on Capitol Hill, Alex Azar fielded questions Wednesday about the Trump administration’s plans to address the opioid crisis and drug prices. Read More
“This policy helps restore the appropriate role of guidance documents and avoids rulemaking by enforcement,” said Associate Attorney General Rachel Brand. Read More
Leading U.S. opioid manufacturers donated millions of dollars to organizations that doubled as advocacy groups, potentially fueling the opioid epidemic, according to the latest report to emerge from the opioids investigation by Sen. Claire McCaskill (D-Mo.). Read More