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CDER

 •  April 11

Premier Pharmacy Labs is voluntarily recalling the following products due to a potential lack of sterility assurance: Product Name/Description Product NDC Number Type of Packaging Indication Premier Pharmacy Labs Lot Number Beyond Use Dates Quantity Shipped Date(s) Distributed Morphine Sulfate (Single Dose Syringe) 2mg/mL Preservative Free...

CDER

 •  April 6

David A. Keire, Ph.D., Director, Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, CDER When scientists in the Office of Testing and Research (OTR) in CDER’s Office of Pharmaceutical Quality (OPQ) need to demonstrate the quality and performance of a drug product, they use a variety of novel...

CDER

 •  March 26

Evaluation of Bulk Drug Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice...

CDER

 •  March 16

Under FDA’s good guidance practices regulations at 21 CFR 10.115(f)(3), external parties can submit drafts of proposed guidance documents for FDA to consider. All proposed draft guidance documents should be marked “Guidance Document Submission” and be submitted either in paper to the address found on the Dockets Management page or...

CDER

 •  March 5

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed below. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this...

CDER

 •  February 13

Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the Retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg,...

CDER

 •  February 9

Meetings between stakeholders and the FDA’s Center for Drug Evaluation and Research (CDER) promote effective two-way communication to improve drug development and safety. To submit your request for a meeting on drug-related topics, please click the Request a Meeting on Drugs button below. Then, complete the meeting request form and click “submit”....

CDER

 •  February 8

These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) and CDER Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters...

CDER

 •  February 7

In general, FDA recommends that any applicant who has not fully addressed elemental impurities in their applications in their current form submit the information as soon as possible. If the application is currently under review, this submission would be considered an unsolicited amendment, and could impact the review clock; however, waiting for an...

CDER

 •  February 5

December 2017 September 2017 The Center for Drug Evaluation and Research (CDER) established the Data Standards Program in 2010. The program leads CDER’s efforts to standardize data and help FDA meet its performance goals under the Prescription Drug User Fee Act (PDUFA) V. Between late 2016 and the end of 2019, several new requirements go into...