We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA’s efforts to improve premarket safety analytics and documentation were met with comments from several drugmakers expressing concerns about standardization and harmonization with other data systems. Read More
Generic drug makers are responsible for providing sufficient information in their abbreviated new drug applications (ANDA) to show that the generic drug’s active ingredient is the same as that of its reference listed drug (RLD), the FDA said in a draft guidance issued today. Read More
In the ongoing saga of the Pasteur Act — a thus-far unsuccessful bill introduced in 2020 to encourage new treatments for fighting drug-resistant pathogens — a group of academics and advocacy organizations sent a letter to Congress contending that the “fatally flawed” bill would squander taxpayer dollars and may exacerbate the threat of antibiotic resistance in the U.S. rather than fix it. Read More
In the latest twist in an ongoing patent case with far-reaching implications, the U.S. Supreme Court will consider Amgen’s petition seeking review of an appeals court decision that invalidated the company’s patent for its blockbuster cholesterol drug Repatha (evolocumab). Read More
Before filing for an orphan medicinal product designation, says the European Medicines Agency (EMA) in a new guidance, sponsors should request a pre-submission meeting to discuss the prevalence of the rare disease, the scope of the application, the drug’s active substance and mode of action and supporting clinical and nonclinical data. Read More
The FDA handed Lupin a warning letter citing the company’s failure to correct cross-contamination issues noted in an inspection of its manufacturing plant in Palghar, India, earlier this year. Read More
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