Topic:

Regulatory

Latest Headlines

Latest Headlines

NYT op-ed slams device breakthrough pathway proposed in 21st Century Cures Act

The 21st Century Cures Act promises to overhaul regulation of the medical device (and biopharma) industry if it passes the Senate. It just passed in the House of Representatives with a strong bipartisan majority. One of the main ways in which it would benefit the device industry is through the creation of a "breakthrough" pathway for critical medical devices.

FDA approves the first implantable, above-the-knee prosthesis

The U.S. Food and Drug Administration has approved an option for patients who have trouble with the standard socket leg prosthetics that are typically used for those with above-the-knee amputation. The implantable prosthetic requires two surgeries, but it's intended to encourage prosthetic usage and to improve patient outcomes.

China FDA issues final classification rules on medical devices

The China FDA has issued revised and final medical device classification rules set to go into effect at the start of next year. The final rules categorize the level of risk posed by devices by noting structural features, intended use, and whether they involve human contact.

Theranos inks Medicaid deal and snags CLIA waiver to expand Dx reach

After scoring FDA approval last week for its finger-stick herpes test and striking its first deal to provide its tests for a private insurer, Theranos is teaming up with a managed care provider to offer its tests to Medicaid patients and snagging a CLIA waiver from the FDA for its herpes testing system.

FDA gives its first nod to St. Jude for an Apple-compatible device to try out pain neurostim implant

The U.S. Food and Drug Administration may have made it a bit easier for chronic pain patients to evaluate whether a spinal cord stimulator could be an effective treatment. For the first time, it's approved a wireless, external device from St. Jude Medical that can be manipulated via an Apple iPod touch, rather than a dedicated controller that's likely to be less intuitive to patients.

FDA may tap Google to beef up drug-safety monitoring

The FDA is planning to team up with tech giant Google to identify previously unknown side effects of meds.

Reuters: WHO, EMA likely to approve GlaxoSmithKline's malaria vaccine despite challenges

Final trial results reported in April showed that the efficacy of GlaxoSmithKline's investigational malaria vaccine wanes over time. But the candidate, dubbed RTS,S or Mosquirix, is the furthest along in the quest for a vaccine and so, may win WHO and EMA approval as the first vaccine against malaria.

Early trends from India survey show TB drug resistance rates less than WHO estimates

Early trends from India's first survey on multidrug-resistant tuberculosis showed a lower rate of infections than World Health Organization estimates in findings that will help shape the government's treatment focus, the Indian Express newspaper reports.

Takeda hands in its Velcade successor with blockbuster ambitions

Japanese drugmaker Takeda is angling to win FDA approval for its lead cancer asset, an oral treatment for blood malignancies that is key to the company's future in oncology.

CFDA eyes new Shanghai evaluation center to speed drug approvals

Shanghai will build a China FDA medicine evaluation center to speed drug approvals,  CNTV  said on its website, as part of efforts to keep and attract drug and device firms to the region.