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Archive for the ‘Drugs’ category

In 2015, the drug and medical device industries saw a turn toward digital. The U.S. Food and Drug Administration (FDA) established new regulations requiring certain documents to be submitted electronically, including pharmaceutical product applications and adverse event reports for devices. FDA also opened an online database for the public to obtain information about devices. Read […]

Outsourcing facilities must complete their annual registration with the U.S. Food and Drug Administration (FDA) between October 1 and December 31, 2015. The fee to register for fiscal year 2016 is $16,465.  The fee for small businesses is $5,203. Outsourcing facilities must also submit drug product reports to FDA between December 1 and 31, 2015, […]

In August 2015, the Federal Trade Commission (FTC) recommended that the U.S. Food and Drug Administration (FDA) reconsider its regulatory framework for homeopathic medicines. FTC’s recommendation was in response to FDA’s April 2015 request for comments on the matter. Unlike most other drug products, homeopathic drugs do not have to be reviewed for safety and […]

The U.S. Food and Drug Administration (FDA) issued a warning letter to Duchesnay, Inc after a social media endorsement posted by U.S. celebrity Kim Kardashian was reported through FDA’s Bad Ad program.  Kardashian published a lengthy post on her Instagram describing her successful experience with Duchesnay Inc’s product DICLEGIS, a prescription morning sickness medicine. “It’s […]

In early August each year, the U.S. Food and Drug Administration (FDA) publishes various user fee rates for the upcoming fiscal year (October 1 to September 30). On August 3, 2015, FDA published its medical device and generic drug user fee rates for fiscal year (FY) 2016. Medical Device User Fees FDA has authority to […]

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