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When future new study data standards are listed in the Catalog, the new standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorizations for 92 drugs and biologics in 2017, an increase from 81 in 2016 but down from 93 in the previous year. Read More
Drugmakers must do more to ensure access to treatments for antimicrobial-resistant superbugs, but GlaxoSmithKline and Johnson & Johnson are doing more than other organizations on 16 metrics of progress, according to the Access to Medicines Foundation, a Netherlands-based non-profit. Read More
The Food and Drug Administration teamed up with the Federal Trade Commission to issue joint warning letters to 11 marketers and distributors of opioid cessation products, for illegally marketing products with unproven claims of treating opioid addiction. Read More
A federal circuit court upheld a PTO Patent Trial and Appeal Board ruling that a Johnson & Johnson patent for Remicade, which earned the company nearly $7 billion in 2016, is invalid. Read More
If the product is mixed, diluted or repackaged in a state or federal pharmacy, it may only be distributed after receiving a valid prescription. Read More