Drugs

CDER Plans 4 Ad/Promo Guidances, Among Dozens of Others

CDER plans to publish four guidance documents this year related to drug industry advertising and promotional activities, along with dozens of other guidances related to biosimilar submissions, conducting clinical trials and manufacturing quality. According to a just-posted guidance agenda, the documents planned for advertising are:

Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices –Use of Links to Third-Party Sites
Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Licensed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices
Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft

CDER said recently that its Office of Prescription Drug Promotion (OPDP) has assigned resources to make guidance development a high priority. OPDP says its current top priorities are policy and guidance development, labeling reviews, core launch reviews and TV ad reviews, enforcement, and training and communications.

Meanwhile, Warning Letters and untitled letters are at an all-time low. OPDP issued nine such letters in 2015, one less than it issued in 2014. This compares with an annual average of 28 between 2011 and 2014. This week, the Office sent its first untitled letter of the year to Hospira over an allegedly false and misleading Youtube video (see story).

According to the guidance agenda, biosimilar guidances to be released this year include:

Considerations in Demonstrating Interchangeability With a Reference Product
Labeling for Biosimilar Products
Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

Under clinical/statistical guidances, CDER has these planned:

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

And under drug safety, the Center says to expect these to be published:

Format and Content of Proposed Risk Evaluation and Mitigation Strategies
Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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