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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 Form 483 reports to facilities in Germany, China, Mexico, South Korea, the United Kingdom and the U.S. for a range of nonconformance issues. Read More
The FDA cited issued warnings letter to drugmakers in Japan, Mexico, Australia and to three in the United States for GMP and other deficiencies. Read More
The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct inspections. 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
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the latest update from the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Read More
The FDA sent a warning letter to Chinese manufacturer Guangzhou Baiyunshan for failing to follow proper cleaning, validation and storage procedures at its Guangzhou, Guangdong facility. 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