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In a move that’s likely to shake up the entire U.S. drug supply chain, President Trump signed an executive order yesterday directing the federal government to buy “essential drugs” from domestic companies. Read More
The FDA released guidance for sponsors of drugs for treatment of life-threatening ailments seeking approval under the agency’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) program. Read More
Almost three dozen state attorneys general have called on the federal government to bypass Gilead Sciences’ remdesivir patents and begin producing the COVID-19 treatment. Read More
The FDA has updated its Purple Book to include all licensed biological products overseen by the Centers for Biologics Evaluation and Research (CBER) and Drug Evaluation and Research (CDER). Read More
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The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling.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