FDA Releases Compounding Policy Priorities
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Source: Drug Industry Daily
China FDA to Require Registration, Training of Medical Reps
China FDA released draft regulations that would require medical representatives in China to register, and mandate that medical product marketing authorization holders provide adequate training. Source: International Pharmaceutical Regulatory Monitor
EMA’s CHMP Recommends Seven Medicines for Approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended seven new products for European Commission approval, including one biosimilar and two orphan medicines, one being an advanced…
Quality System Issues Dominate MHRA’s GDP Report
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Source: International Pharmaceutical Regulatory Monitor
Senate Committee Grills Azar on Eli Lilly Price Hikes
Alex Azar, President Trump’s nominee for Secretary of Health and Human Services, emphasized his view that “drug prices are too high” to the Senate Finance Committee, even as Democrats continued…
International Drugmakers Plan for Higher Costs as Brexit Looms
Testifying before a UK House of Commons committee last month, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making…
FDA to Expand Least Burdensome Approach Across Product Lifecycle
The FDA said in a new draft guidance a “least burdensome” approach should be applied throughout the medical device total product lifecycle, rather than just in premarket activities. Source: The…
TGA Logs More Adverse Event Reports for Devices
Australia’s Therapeutic Goods Administration saw a significant increase in adverse event reports for medical devices in 2016 — logging 3,841 AERs compared with 3,359 the previous year — according to…
483 Roundup: Thirteen Device Firms Cited for Noncompliances
The FDA flagged 13 devicemakers for serious deficiencies including inadequate reporting of adverse events, and CAPA nonconformities. Source: The GMP Letter
CDRH Proposes New Medical Device Malfunction Reporting Program
CDRH is proposing a new industry program for reporting certain medical device malfunctions. Source: The GMP Letter
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