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Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active ingredients of Lovenox and Heparin. Read More
FDA’s Office of Regulatory Affairs Announced New Ombudsman
Teva Receives Complete Response Letter for Epinephrine ANDA
AZ Divests Rights to Moventig Read More
Arlington, Texas-based dietary supplement maker Waisted with Lucy was stuffed with violations, as an FDA warning letter dinged the firm for the sale of unapproved and misbranded drugs. Read More
The U.S. Attorney’s Office for the Southern District of New York issued a subpoena to Horizon requesting information related to its patient assistance programs, the drugmaker disclosed in an SEC filing. Read More
A report from AARP contends that prices for prescription drugs widely used by retirees consistently outpaced inflation between 2006 and 2013, the most recent year for which complete data was available. Read More
FDA Lifts Clinical Hold on RespireRX’s Respiratory Depression Drug
Roche’s Asthma Candidate Nets Conflicting Results in Late-Stage Studies
Sellas Life Sciences Wins Orphan Drug Designation for WT1 Cancer Vaccine Read More
The European Medicines Agency has begun a public consultation on revised module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans should focus on over a product’s lifecycle. Read More
Refuting testimony provided by CDER Director Janet Woodcock during a Senate HELP Committee hearing, Sen. Tom Cotton (R-Ark.) sent a letter to new FDA Commissioner Robert Califf seeking information on the agency’s ANDA backlog. Read More