This post was written by Paul Sheives. FDA will hold a 2-day public meeting on July 27 and 28, 2010 to address the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biological products. The purpose of the meeting is to seek public input on various concerns that stakeholders have raised
Biologicals
FDA to Post New On-line Information Regarding Safety Monitoring Issues for Recently-Approved Drugs and Biologics
By Debra A. McCurdy on
This post was written by Paul Sheives.
FDA announced a new initiative, required under the Food and Drug Administration Amendments Act of 2007, to post summaries of FDA safety analyses and the agency’s plan to address them on the FDA website. Because evidence of some side effects arises following approval of the products, FDA is…
FDA Review of Articles for Treatment of Rare Diseases
By Debra A. McCurdy on
FDA is hosting a meeting June 29 and 30 on “FDA Review and Regulation of Articles for the Treatment of Rare Diseases.” The hearing is intended to provide stakeholders, including the pharmaceutical industry, with an opportunity to present their views on the way FDA regulates the scientific evaluation of, marketing authorization for, and postmarket …
CMS Transmittals on Discarded, Self-Administered Drugs/Biologicals
By Debra A. McCurdy on
CMS has issued a Medicare Claims Processing Manual update regarding discarded drugs and biologicals, including language regarding use of the JW modifier (“Drug or Biological Amount Discarded/Not Administered to Any Patient”). The manual update is effective July 30, 2010. In addition, CMS has updated its manual language relating to Determining Self Administration of Drug or…
Proposed Rule Amending Informed Consent Disclosure
By Debra A. McCurdy on
This post was written by Paul Sheives. On December 29, 2009, the Food & Drug Administration Act (FDA) issued a proposed rule that would amend the informed consent regulations to require the addition of an element regarding disclosure of information to the National Institute of Health (NIH) clinical trials database. Under the Food…
FDA Guidance Documents
By Debra A. McCurdy on
This post was written by Paul Sheives.
FDA recently released two guidance documents (one in draft form) concerning hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C), which provide information to manufacturers seeking licensure and potential sponsors for Investigational New Drugs Applications (INDs). FDA announced that it no longer intends to exercise enforcement…