Drugs

CDER Posts Guidance Agenda for 2018

CDER has released its guidance agenda for documents its plans to release in 2018. It includes two related two drug advertising: “Presenting Quantitative Information in Direct-to-Consumer Promotional Labeling and Advertisements” and “Updating Promotional Materials to Reflect Labeling Changes to Risk Information.” Under clinical/statistical planned guidances, the agenda lists the following:

Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft
Adjusting for Covariates in Randomized Experiments
Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products

And under the category of pharmaceutical quality, CDER says it plans to issue these guidances:

CDER’s Program for the Recognition of Voluntary Consensus Standards
Clarification of Human Drug Application Establishment Information Q&A Guidance
Drug Master Files; Revised Draft
Harmonizing Compendial Standards with Drug Application CMC Approval
Requirements Using the USP Pending Monograph Process
Identification of Manufacturing Establishments in Applicants Submitted to CBER and
CDER – Questions and Answers
In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products
Metered Dose Inhaler (MDI) and Dry P owder Inhaler (DP I) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft
Post-Approval Changes to Drug Substances (GDUFAII)
Product Development and Quality Control of Transdermal and Related Delivery Systems
Quality Considerations for Continuous Manufacturing (CM)
Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction
Utilizing a Device Part with Electronics or Software
Use of Liquids and/or Soft-Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments
Using the Inactive Ingredient Database

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