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The agency suggests decentralizing trials and broadening inclusion criteria to include as many different types of subjects as possible in trials. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Kowa Pharmaceuticals for a video that makes false and misleading claims for its high cholesterol drug Livalo (pitavastatin). Read More
The FDA has issued a complete response letter to AstraZeneca for its NDA for PT010 — a three drug combination product for treatment of chronic obstructive pulmonary disease (COPD). Read More
The FDA daily intake limit for NDMA is just 96 nanograms for the probable human carcinogen. The company claimed that it detected levels in excess of 3 million nanograms per tablet. Read More
The FDA yesterday issued a 49-page draft guidance on how industry should go about asking patients what’s most important to them about how they are dealing with their disease and its treatment, to help companies better develop new drugs. Read More
A bellwether trial jury in Louisiana cleared Sanofi of liability over claims that it failed to issue adequate warnings that its chemotherapy drug Taxotere (docetaxel anhydrous) could cause permanent hair loss. Read More
In a first for the agencies, the FDA and the Drug Enforcement Administration issued joint warning letters to four website operators for illegally selling opioids. Read More