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With just two months left in the fiscal year and an average of 67 approvals a month, the agency is poised to break the previous year’s record. Read More
The FDA released final guidance Tuesday for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on software. Read More
FDA Commissioner Scott Gottlieb repeated the agency’s commitment to biosimilars and stakeholders urged the agency to do more to improve market access during a public meeting Tuesday. Read More
Westminster Pharmaceuticals recalled two of its thyroid drugs after manufacturing them with APIs sourced from a Chinese supplier the FDA cited for GMP violations. Read More
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Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention.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