Category Archives: Regulatory

New CDER “Super Office” to Promote Drug Quality

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research, has administration approval for organizational changes to bolster programs and policies to ensure drug quality. The Department of Health and Human Services and the White House have finally signed off on her plan to establish a new CDER […]
Also posted in FDA | Tagged , , , | Leave a comment

Market Access in Ukraine

by Lana Sinichkina  and Leonid Cherniavskyi. On September 16, 2014, the Ukrainian and European parliaments ratified the EU–Ukraine Association Agreement (AA), providing for harmonization of many spheres of Ukrainian legislation with EU policy. In line with the signed AA, the government has adopted a detailed implementation plan, which endorses for preparation and approval by the […]
Also posted in Europe, Global, Guest Blog, healthcare, Op-Ed, pricing | Tagged , , , | Leave a comment

Five Measures to Cope with the Side Effects of Health Reform

By Sydney Rubin. With more than 8 million Americans now signed up for health insurance through state health exchanges, The Affordable Care Act (ACA) has begun delivering benefits and new insurance protections to a large swath of Americans, many of whom had no health insurance before. People previously rejected by insurers due to pre-existing conditions […]
Also posted in Guest Blog, healthcare, Op-Ed, pricing | Tagged , , , | Leave a comment

US Company Awarded UK's First "Promising Innovative Medicine" Designation

By Leela Barham. The UK’s Medicines and Healthcare Regulatory Authority (MHRA) has awarded Northwest Biotherapeutics, Inc. (Bethesda, MD) the very first “Promising Innovative Medicine”, or PIM designation, for the company’s DCVax-L product.
Also posted in Europe, Global, Guest Blog | Tagged , , , | Leave a comment

EMA Calls Out to Companies Developing Ebola Treatments

The European Medicines Agency (EMA) is reviewing available information on Ebola treatments currently under development to “facilitate evidence-based decision-making” by health authorities. At the moment there are no approved medicines to protect from or treat Ebola. Some experimental treatments have reportedly shown encouraging results in the laboratory or in animals, but they have not yet […]
Also posted in Europe, Global, healthcare | Tagged , , | Leave a comment
  • Categories

  • Meta