With just days remaining until the “Deemed to Be a License” transition takes effect, the FDA issued an unexpected sweeping change to compounding practice. ...more
Food/Dietary Supplements -
FDA Provides Update on Frozen Berry Sampling – The FDA stated, “As of September 30, 2019, the FDA has tested 339 domestic samples and 473 import samples of frozen berries. ...more
Food/Dietary Supplements -
FDA Releases Food Contact Guidance – The FDA published a guidance titled “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk:...more
Food/Dietary Supplements - FDA Investigates Salmonella Concord Outbreak – FDA continues to investigate a multistate outbreak of Salmonella Concord linked to imported tahini products....more
On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics Price Competition and Innovation Act of 2009 (BPCI). First, is an injunction...more
Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance...more
On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more
4/23/2015
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drug Coverage ,
Prescription Drugs