FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Herbal Doctor Remedies Monterey Park, CA (5/25): FDA inspected the firm 11/2016 and reviewed product labeling/claims and determined that its herbal products are unapproved drugs. The agency said the products require FDA approval because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm561127.htm

Prestige Brands Holdings, Tarrytown, NY (6/1): FDA recently reviewed the firm’s listing information for PediaCare Children’s Plus Multi-Symptom Cold, and PediaCare Children’s Plus Flu and it determined they included inaccurate information. The agency’s review revealed that while the active ingredient, phenylephrine hydrochloride, appears on the copy of the label provided with the listing for each product, it is missing from the listing information in structured product labeling submitted for both drug listing files. FDA removed the products’ listing data from its NDC Directory and it will not be available for public viewing until corrections are made.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm561702.htm

Yusef Manufacturing Laboratories, Clearfield, UT (5/25): FDA inspected the firm’s drug manufacturing facility 5/2016 and cited significant GMP violations. For example, the firm failed to thoroughly investigate unexplained discrepancies. Additionally, the firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm561629.htm

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