- Why FDA Should Oversee Laboratory Developed Tests (blogs.fda.gov)The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies (fda.gov)Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) DRAFT GUIDANCE (fda.gov)Theranos isn’t the only diagnostics company exploiting regulatory loopholes (theverge.com)
Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDT) – tests that are designed, manufactured and used in a single laboratory…But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients...LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results...FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT...the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients…FDA has proposed to step up our oversight of LDTs. We issued a draft guidance last year which we’re currently working to finalize, that proposes to phase in enforcement of premarket review requirements for LDTs. FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.
- DEA Announces Major Steroid Operation – Operation Cyber Juice: U.S., global takedown includes home labs, gyms, local distributors (dea.gov)
DEA officials today announced a nationwide series of enforcement actions targeting every level of the global underground trade of anabolic steroids and other performance-enhancing drugs,…manufactured and trafficked from underground labs in China…Operation Cyber Juice …resulted in the arrest of over 90 individuals, the seizure of 16 underground steroid labs, approximately 134,000 steroid dosage units, 636 kilograms of raw steroid powder, 8,200 liters of raw steroid injectable liquid, and over $2 million in U.S. currency and assets.
- TruTag, WuXi PharmaTech successfully test edible, on-dose authentication
Testing on an edible on-dose authentication technology developed by TruTag Technologies is showing promising results for its use in combating counterfeit drugs…TruTech partnered with WuXi PharmaTech,…technology that can store a drug’s provenance information on individual tablets. The silica, dust particle-sized TruTags act like bar codes that can provide information about where a drug was manufactured and its dosage, as well as supply chain details like lot or batch number...