Category Archives: Regulatory
By Pharm Exec | Published: October 23, 2014
This month’s special issue of Pharm Exec Global Digest looks at Dealing with the “side effects” of Obamacare The “value” of Rxs under Obamacare The escalating cost of US oncology care And more… Click here to read the issue.
By Jill Wechsler | Published: October 17, 2014
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 […]
By Guest Blogger | Published: October 13, 2014
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 […]
By Guest Blogger | Published: October 3, 2014
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 […]
By Guest Blogger | Published: September 30, 2014
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.