Drugs

Evaluate GDUFA Changes to See if Needed: GPhA

The Generic Pharmaceutical Association (GPhA) says that the new Generic Drug User Fee Agreement (GDUFA) program has had significant impact on both the industry and the agency and there have been enormous changes to ensure the success of all parties. “As we transition from GDUFA 1 into GDUFA 2, we need to evaluate all changes to determine those that are necessary and required from those that are not necessary/required,” the association says in a comment letter. “GPhA would like to request that FDA undertake this evaluation of all past, present and future changes under GDUFA 1 and as we go into GDUFA 2 that are in line with new requirements and mandates.”

The group asks FDA to consider two questions in its evaluation:

does the process change and/or mandate improve the review and approval process by making it more streamlined and efficient; and
what significance, if any, does the new process change and/or mandate contribute to the approvability of an ANDA application in determination of safety or efficacy.

“If the answer to either or both of these questions is none, then the agency must discontinue the process(es) as they are an unnecessary burden on both the agency and industry,” GPhA says. “In our current climate of cost controls and containment across industry and government alike, especially the cost of medicines to the end user, the patient, we as an industry and FDA as the regulator must pause and give more thought as to how we are unintentionally adding to the burden and bottom-line costs of our organizations. Any unnecessary processes and/or mandates will only over-burden both industry and FDA and will lead to the unintended consequence of delaying generic competition and access to more affordable medicines to the American public.”

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

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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