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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
The FDA requested stakeholder feedback on its 2003 guidance on exposure-response analyses — prompted by PDUFA VI provisions on advancing model-informed drug development. Read More
India’s Central Drugs Standard Control Organization is creating a national database of pharmaceutical manufacturers, and will require reporting of facility and product details for inclusion in the database. Read More