Senate Vote Planned on Federal Right-to-Try Bill September 28, 2016 An FDA official testified before a Senate panel on the agency’s expanded access programs. Read More
FDA Labels Magnetic Surgical Instrument Systems as Class II September 27, 2016 Firms that intend to market this type of device must submit a premarket notification. Read More
Diabetes Drugs Are Clinical Pipeline’s Dodgiest Division, Tufts Study Finds September 27, 2016 Diabetes medications in the clinical pipeline are less likely to enter Phase III testing. Read More
House Committee Rebukes Mylan CEO, FDA Official on EpiPen Fee September 26, 2016 Mylan CEO grilled on virtual monopoly of the epinephrine auto-injector market. Read More
Apotex Requests Supreme Court to Review Six-Month Notice for Biosimilars September 26, 2016 They want the high court to decide whether the 180-day notice is mandatory. Read More
Australia Issues Warning for Smith & Nephew Tandem Bipolar Hip System September 23, 2016 The firm discovered that some devices were manufactured with a retainer groove that is out-of-specification. Read More
Patient Involvement Emphasized by Health Council in Advice to Next President September 23, 2016 The council was among more than 100 thought leaders recruited by the National Academy of Medicine to weigh in on health care reform. Read More
Holes in Packaging Compromise Sterility of Ecolab Klerpack Syringes September 22, 2016 The company alerted users to quarantine affected stock and perform a risk assessment. Read More
Knowledge Gap Leaves Physicians at a Disadvantage on Pediatric Opioid Painkillers September 22, 2016 Committees discussed how physicians don’t have a confirmed opioid dosing regimen for children. Read More
Australia’s TGA Releases Guidance on Registering Class IV In Vitro Diagnostics September 21, 2016 Sponsors need to first submit manufacturer evidence, and the TGA needs to approve it, before applications can be submitted. Read More
Teva Recalls Four Drugs Produced at Hungary Plant September 21, 2016 According to Teva, the recalls began in June. Read More
NICE Vouches for IUD as Emergency Contraception September 20, 2016 The IUD can be used as an emergency method of contraception within five days. Read More