Drugs

Stakeholders Want Changes to Supply Chain Guidance

While praising FDA efforts to develop guidances and standards to implement the Drug Supply Chain Security Act, four industry stakeholders are seeking changes to a draft guidance on the interoperable exchange of information for tracing of certain human, finished prescription drugs.

The American Pharmacists Association (APhA) says the information guidance is only one of several guidances addressing the enhanced drug distribution security requirements. “Trading partners cannot adequately prepare systems and processes for the enhanced requirements until the full roadmap is finalized….,” APhA says. “APhA urges FDA to finalize these guidances soon to provide sufficient time for implementation and compliance by 11/27/23.”

Pharmaceutical Research and Manufacturers of America (PhRMA) writes that FDA should provide guidance for non-EPCIS (Electronic Product Code Information Services) standards. It says the agency should include in the final guidance an explicit acknowledgment that Web portals are an acceptable method to exchange information. PhRMA also lists several topics for which it believes additional clarification is needed.

The Healthcare Distribution Alliance lists several comments it would like to see addressed in the final guidance.

Finally, the Association for Accessible Medicines says it and its members commend FDA for its endorsement of EPCIS. The association asks for clarification on whether the revised draft guidance replaces an 11/2014 draft. It says the clarification is needed because the 2014 document specifically endorsed the use of data portals and emails as acceptable interoperable methods to make information available to trading partners and the current draft is silent on their use. “Data portals and emails are ingredients of our members’ 2023 plans to establish interoperable data exchange with some of their trade partners, notably small dispensers,” the association says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome