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None of the 10 largest U.S. drugmakers have lowered prescription drug prices as a result of the tax reform passed in 2017, according to an analysis from the office of Sen. Cory Booker (D-N.J.). Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts. Read More
The House passed an omnibus spending bill on March 22 that boosts FDA funding for medical product safety activities by $113.2 million, including a one-time payment of $94 million to expand FDA’s surveillance efforts at international mail facilities to address the opioid crisis. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency released new guidance on its approach to GXP data integrity and its expectations for achieving compliance. Read More
The group said the federal government has, in the past, “asked recipients of federal grants and contracts to correct failures to disclose federal funding” but has not used its rights to claim patent titles and influence drug prices. Read More
HHS should claim five patents on Serepta Therapeutics’ Exondys 51 (eteplirsen), a drug used to treat Duchenne muscular dystrophy, and use the patents as leverage to lower the drug’s price, said six advocacy groups in a letter to Health and Human Services Secretary Alex Azar. Read More
CDER’s Office of New Drugs issued a new manual of policies and procedures, effective immediately, concerning NDAs for parenteral drugs that will be packaged in plastic immediate containers. Read More
FDA drug fraud investigations increased by nearly 50 percent in fiscal 2017 reaching an all-time high since the agency began participating in the Health Care Fraud and Abuse Control Program in 2011, according to the HHS Office of Inspector General. Read More
When choosing and justifying starting materials, applicants should consider both the general principles in ICH Q11 and the clarifications in the Q&A document, according to the guidelines. Read More