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In a case that centered on labeling, an appeals court overturned a federal court ruling that GlaxoSmithKline was liable for the suicide of an attorney who took a generic of its antidepressant drug Paxil (paroxetine). Read More
Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention. Read More
The FDA issued final guidance on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Read More
The FDA finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products. Read More
Sponsors of generics for Pfizer’s estrogen drug Premarin should use the “Pfizer method” for assessing sameness rather than the method recommended in FDA draft guidance, the company said in a citizen petition. Read More
Purdue agreed to pay rival opioid manufacturer Assertio Therapeutics $62 million to settle Assertio’s patent infringement lawsuit against the OyxContin maker. Read More
A federal judge in the US. District Court for the Eastern District of California threw out PhRMA’s case contesting state drug pricing legislation, but left the door open for an amended filing. Read More
In an Aug. 30 notice, the agency said meeting requests should include key features of the statistical analysis plan, as well as the simulation plan and components of the study design the sponsor believes are non-disclosable. Read More
The FDA’s ongoing investigation of Zhejiang Huahai Pharmaceuticals looked at the company’s API manufacturing process and changes made to it over time. Read More