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The FDA found numerous faults during inspections this year of the PharmaTech facility in Davie, Fla. — resulting in the agency issuing a Form 483 that described shortcomings in product-testing, packaging, labeling, and other procedures at the facility. Read More
New guidance from the UK’s National Institute of Health and Care Excellence links the cost-effectiveness of different bisphosphonate medications for osteoporosis with a patient’s 10-year risk of bone fractures. Read More
The European Medicines Agency published an internal guide on the use of multinational assessment teams for pre-authorization reviews and post-authorization extensions for new medicines. Read More
New Hampshire has joined the long list of states to take legal action against Purdue Pharma, maker of OxyContin (oxycodone), the company’s extended-release prescription opioid painkiller. Read More
Tasked with thinking beyond the agency’s current policy proposals, the FDA created a new working group of senior staff members to develop ways to boost generic competition, according to Commissioner Scott Gottlieb. Read More
A class action lawsuit claims that Beijing-based Sinovac Biotech misled shareholders and bribed regulators at the China Food and Drug Administration to expedite its drug and clinical trial applications. Read More
The European Medicines Agency revised its guideline on first-in-human clinical trials, highlighting the sponsor’s responsibility for mitigating risks to volunteers.in the study design. Read More
Data integrity, recordkeeping and drug trial oversight violations feature in the UK Medicines and Healthcare products Regulatory Agency’s latest report on good clinical practice inspections. Read More
The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design. Read More
A joint FDA advisory committee voted against recommending approval of Intellipharmaceutics’ extended-release opioid painkiller Rexista, as well as against the claim that it deters abuse. Read More