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The FDA has adopted the final version of an International Conference for Harmonisation (ICH) guidance on the validation of bioanalytical methods and studies. Read More
New 24-month data will delay the FDA’s decision for Apellis Pharmaceuticals’ investigational therapy for the rare eye disease geographic atrophy (GA) until February, but — according to the company — will strengthen the case for approval. Read More
The Centers for Disease Control and Prevention (CDC) has revamped its recommendations for prescribing opioids, nixing controversial dose and duration limits from 2016 that critics say hurt patients who needed opioids. Read More
The Orphan Drug designation is for drug or biological products to prevent, diagnose or treat rare diseases or conditions that affect fewer than 200,000 patients in the United States. Read More
Sponsors should be prepared to discuss proposed labeling for combination oncology drug regimens with the FDA in pre-application meetings, the agency said in a final guidance released yesterday. Read More
Sovereign Pharmaceuticals, a contract development and manufacturing organization (CDMO) based in Fort Worth, Texas, has received an FDA warning letter citing multiple quality control issues that led to inconsistent tablet weights. Read More
The FDA is changing its definition of face-to-face meetings to clarify that they include both in-person meetings and virtual meetings on audio- and video-enabled platforms. But at the moment it won’t be holding in-person meetings. Read More
AbbVie has filed a complaint against several generics producers — including Teva Pharmaceuticals and Novartis’ Sandoz unit — alleging the companies infringed on patents for its endometriosis drug Orilissa (elagolix) by planning to make generic alternatives. Read More
An FDA advisory committee voted 13-0 yesterday in favor of the agency’s long-term strategy for its Knowledge-Aided Assessment and Structured Application (KASA) program, including expanding it from just generic drugs to new drugs and biologics assessments over the next five years. Read More