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The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling.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
The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling.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
Maryland-based Emergent BioSolutions was the government’s highest-paid drug or vaccine vendor as of mid-June at $643 million, out of nearly $9 billion issued by HHS for COVID-19, according to a new report released yesterday by the Government Accountability Office (GAO). Read More
Calls for clarification of FDA guidance on interpreting the sameness of gene therapies under orphan drug regulations featured in comments submitted to the agency. Read More
The FDA offers recommendations to sponsors for setting endotoxin limits for early and late-stage development of investigational oncology products in a draft guidance released yesterday. Read More
Following the cancellation of a meeting yesterday at the White House to discuss drug pricing, PhRMA and BIO have come out strongly against a Trump administration executive order that would require Medicare to purchase certain drugs at the lower prices paid by other countries, arguing that the move will hurt innovation and the industry’s efforts during the COVID-19 pandemic. Read More