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Average out-of-pocket costs for prescription drugs have gone down in the past five years for insured patients, while prices for the uninsured paying cash have increased, IQVIA reported. Read More
The European Medicines Agency (EMA) has issued a proposed five-year pharmaceutical regulatory plan with six areas of focus including improvements in the drug supply chain. Read More
As a result of the COVID-19 pandemic, the FDA has extended its enforcement discretion policy for six months for manufacturers of stem cell products to submit marketing applications to the FDA. Read More
The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) continues to extend what it calls temporary “flexibilities” in good manufacturing practice (GMP) to drugmakers to help out with the exceptional circumstances imposed by the current COVID-19 pandemic. Read More
A federal judge in Florida has recommended denying Catalyst Pharmaceuticals’ complaint against the FDA over the agency’s approval of a rare muscle disease drug similar to its own drug Firdapse (amifampridine). Read More
Sponsors of drugs and biological products for preoperative treatment of high-risk early-stage breast cancer can qualify for the FDA’s accelerated approval pathway if they use pathological complete response (pCR) as an endpoint, according to a final guidance released last week. Read More
The FDA has unveiled its user fees for prescription drug applications for fiscal year 2021 — slightly trimming some fees that increased by double digits for fiscal 2020. Read More
In a new guidance on unit-dose repackaged solid oral drugs, the FDA said it will generally not take action on nonconformance with requirements for expiration dating if certain requirements are met. Read More