FDA Adds 24 Entries to List of Drugs That Are Prohibited in Compounding October 14, 2016 The drugs on this list may not be compounded under exemptions provided by sections 503A and 503B. Read More
Device Manufacturers Want Faster Track for Antimicrobial Susceptibility Tests October 13, 2016 In the clinical setting, some physicians are reluctant to prescribe new antibiotic treatments. Read More
FDA Lists Safety Concerns, Suggests Trials for Head Lice Treatments October 13, 2016 Use of a lice comb as part of the treatment regimen could affect efficacy. Read More
‘SkinPen’ Doesn’t Merit Dermabrasion Exemption, Warning Letter Says October 12, 2016 The agency deemed the SkinPen dermabrasion product adulterated. Read More
Guidance on Sanitation at Compounding Facilities Gets Mixed Reviews October 12, 2016 One commenter questioned the need for the guidance. Read More
Documentation, Contamination Issues Draw 483 for Chinese Implant Company October 11, 2016 The dental implant manufacturer failed to implement procedures to prevent contamination. Read More
FDA Completes Guidance on Tropical Disease Priority Review Vouchers October 11, 2016 The agency also loosened its restrictions on the eligibility of drug-drug combinations. Read More
Theranos Closes Blood-Testing Facilities, Cuts 340 Workers October 10, 2016 Closings will affect roughly one-fourth of the company’s workforce. Read More
cGMP Violations Draw Warning Letter for Brazilian Company October 10, 2016 Investigator found quality control unit failed monitor the drug product. Read More
FDA Fast Tracks Combination Aerosol Treatment for Infants in Respiratory Distress October 7, 2016 Aerosurf delivers aerosolized KL4 surfactant to premature infants. Read More
483 Impedes U.S. Expansion for India’s Second-Largest Drugmaker October 7, 2016 The 483 cites nine observations at the Lupin facility. Read More
Australia Releases Alert on Stryker Femoral Heads October 6, 2016 Device components are used in total hip replacement procedures. Read More