Drugs

Comments Offered on e-Submissions of Manufacturing Info

Genentech says it supports FDA’s consolidation and move to electronically coded manufacturing establishments information. Late last year, the agency published a draft guidance, Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, discussing the requirements and implementation of the Federal Food, Drug, and Cosmetic Act on valid electronic submissions of manufacturing establishment information (MEI). The document says that 24 months after the draft has been finalized, MEI in NDAs, ANDAs, BLAs, and amendments, supplements, or resubmissions of these application types must be submitted electronically in the format specified in the guidance.

In just-posted comments on the guidance, Genentech recommends alignment and use of an international common standard in the electronic transmission of registration information. “For example, the use of ISO IDMP Health Informatics standard (e.g. ISO 11615) for Manufacturing Establishment Information was not discussed in the draft guidance,” it says. “While this may be implied by the development of the standard in conjunction with the Common Product Model in HL7 (e.g. use of HL7 V3 messaging to transmit information), additional elaboration and clarity would be helpful.”

In separate comments to the agency, the Active Pharmaceutical Ingredients Committee (APIC) says that the “MEI is an additional submission of information which is already available to FDA by different means. Establishment information for drug substance manufacturers is submitted via CTD section 3.2.S.2.1 (per application or [Drug Master File]. Establishment information is also contained in the ‘administrative page’ being part of the Annual Report on the Master File... On a higher level, MEI information is also submitted to FDA via the electronic site registrations (not per application but per site).”

APIC also recommends that FDA reassess existing guidances to clearly define the information they want to see in CTD section 3.2.S.2.1. This could eliminate the “administrative page” of the Annual Report pertaining to a Master File to avoid excessive documents, the group 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