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. Source: Drug Industry…
Westminster Pharmaceuticals recalled two of its thyroid drugs after manufacturing them with APIs sourced from a Chinese supplier the FDA cited for GMP violations. Source: Drug GMP Report
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…
In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections…
The FDA issued Form 483s to three companies for an array of issues, such as poor recordkeeping and inadequate employee training. Source: Drug GMP Report
The FDA hit five facilities with warning letters, citing them for multiple violations, including a failure to test for conformity. Source: Drug GMP Report
Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention. Source: Drug GMP Report
The U.S. District Court for the District of New Jersey issued a permanent injunction barring online distributor Just Enhance from illegally selling sexual enhancement products on more than 100 websites.…
A European Union task force released a two-year plan on Wednesday to prevent or deal with drug shortages in the region. Source: Drug Industry Daily
In the latest CMS move aimed at reducing drug prices, Administrator Seema Verma released new guidance on how Part D plan sponsors can negotiate formulary coverage based on specific indications…