FDA issued a warning letter to Biotek after a review of its website found some of its products were intended for use as drugs. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Celltrion received two complete response letters from the FDA regarding biologics license applications for Truxima (rituximab) and Herzuma (trastuzumab) — biosimilars of Roche`s blockbuster cancer drugs Rituxan and Herceptin. Source:…

The FDA published a new draft guidance on the scientific and ethical considerations for including pregnant women in clinical trials, telling sponsors that data are needed to inform safe and…

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 FDA requested stakeholder feedback on its 2003 guidance on exposure-response analyses — prompted by PDUFA VI provisions on advancing model-informed drug development. Source: Drug Industry Daily

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. Source: Drug…

A lawsuit from the federal government and 31 states accuses McKesson Corp. of repackaging “overfill” cancer drugs and fraudulently billing federal and state governments. Source: Drug Industry Daily

Internet service providers, social media companies, and other prominent members of the Internet economy need to help identify and remove illegal offers to distribute opioids, FDA Commissioner Scott Gottlieb said…

Osiris Therapeutics filed a lawsuit against MiMedx Group for alleged theft of its clients and pre-paid commissions to Osiris’ longtime distributor Stability Biologics. Source: Drug Industry Daily