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An FDA associate commissioner and five associates are pushing for greater transparency around complete response letters issued to drugmakers when marketing applications are denied. Read More
A citizens advocacy group is accusing the FDA of wrongly expanding the indication of Vanda Pharmaceuticals’ sleep disorder drug Hetlioz by labeling it for use in sighted people. Read More
Sponsors of applications for drugs that are highly soluble in water but not easily absorbed through the intestines can now request waivers of studies proving the drug has a systemic effect or is equivalent to a reference product. Read More
Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, regulators say. Read More
The FDA wants sponsors of investigational drugs and biologics to use the Logical Observation Identifiers Names and Codes to identify laboratory results from clinical studies in regulatory submissions, and is asking for suggestions on how it might assist firms in adopting the codes. Read More
The FDA is asking clinical investigators who sponsor trials to submit many of the elements that a commercial sponsor would include in an investigational new drug application. Read More
The FDA has updated its guidance on refuse-to-receive criteria for ANDAs to include a reference to the Office of Pharmaceutical Quality, which didn’t exist when the guidance was finalized. Read More
A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
For the second time in two days, the FDA has recommended approval of a PCSK9 inhibitor as an effective and relatively safe means of lowering bad LDL cholesterol. Read More