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Sponsors of investigational new drug (IND) applications or biologic license applications (BLAs) for a therapeutic protein should take a risk-based approach to assess the need for drug-drug interaction (DDI) studies, the FDA said in a new draft guidance. Read More
Drugmakers successfully completed a majority of postmarketing requirements and commitments in fiscal 2019, the FDA said it its latest annual report. Read More
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