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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Bicooya Cosmetics Ltd. and ImprimisRx.

Declare Elysium Health Basis Supplement Adulterated: ChromaDex

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ChromaDex asks FDA to declare Elysium Healths Basis supplement product to be adulterated because it uses an ingredient that is not...

Comments Sought on Informed Consent Exception for Diagnostics

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Federal Register notice: FDA is seeking comments on an information collection extension for Medical Devices; Exception From Genera...

Pediatric Advisory Committee to Conduct Safety Reviews

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Federal Register notice: FDA announces a 9/11-12 Pediatric Advisory Committee meeting in Rockville, MD to conduct pediatric-focuse...

Product-Specific Estring BE Guidance Needed: Pfizer

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Pfizer asks FDA for a product-specific guidance on demonstrating bioequivalence to its Estring vaginal ring.

FDA Says Organogenesis Owes a Gintuit Pediatric Study

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FDA says that Organogenesis has not submitted a required pediatric study for its Gintuit allogenic oral soft tissue product.

Odefsey Labeling Changes Approved

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FDA approves changes to labeling for Gileads Odefsey to add 48-week data from trials in which subjects switched to Odefsey from ei...

FDA Nixes Data Package on Cardiome NDA Proposed Resubmission

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FDA tells Cardiome Pharma that a data package proposed by the company would not be sufficient to support a resubmission of its NDA...

Docket Established for DTC Risk Info Recommendations

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Federal Register notice: FDA establishes a public docket to assist with its development of recommendations on the communication of...

Facility Information Pre-Submission Guidance Being Revised

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FDA says it will revise a draft guidance on submission of facility information for expedited priority ANDA reviews in response to ...