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The FDA issued a warning letter to Maryland-based Izeen Pharma for significant violations of current good manufacturing practices and misbranding of its thyroid tablets. Read More
The European Medicines Agency released two guidances on medicine shortages for drugmakers and EU regulators — and said the lack of a common definition has meant that the management of shortages in the European Union has been “inconsistent.” Read More
The FDA on Monday announced that it will give priority reviews to ANDAs for opioid overdose treatments to help address the ongoing public health emergency. Read More
Capping the total number of biologic patents that can be litigated at “a reasonable number” would help biosimilar developers enter the market, AAM said. Read More
President Trump announced on Friday that he may issue an executive order to mandate a “favored nations” approach whereby the U.S. will pay no more than the lowest nation’s price for drugs. Read More
The FDA released final guidance on compounding of oral oxitriptan drugs for patients with tetrahydrobiopterin (BH4) deficiency — a rare condition caused by gene mutations — saying the agency doesn’t intend to take regulatory action against pharmacists or physicians using the bulk drug to compound oral drugs for those patients. Read More
Specialty pharmaceutical company US WorldMeds has asked the FDA to require that generic competitors for its treatment for advanced Parkinson’s disease get approval for both the medication and the medical device components of the injectable. Read More