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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
Health Canada adopted the ICH’s Q&A guideline on the development and manufacture of drug substances as well as a separate guidance on residual solvents. Read More
Soon after classifying kratom as an opioid, the FDA issued a mandatory recall for all of a Las Vegas company’s products made with the substance. Read More
The agency also asked for comments on the aspects of exposure-response analyses that are most important during the drug development or regulatory decision-making process. Read More
Gottlieb said the FDA will host a meeting with senior representatives and CEOs of internet stakeholders, in addition to academics and advocacy groups, to identify solutions. Read More
The Chinese government unveiled a new policy whereby some generics manufacturers could qualify for a “high-tech enterprise” designation, making them subject to a 15 percent corporate tax rate compared to the 25 percent rate paid by other companies. Read More