Drug GMP Report

The Office of Generic Drugs (OGD) has issued a clarification identifying the information that will be considered acceptable for demonstrating compliance with the new U.S. Pharmacopeia (USP) standard for controlling residual solvents.

The FDA is questioning a decision by Novartis subsidiary Sandoz to continue distributing generic versions of Toprol XL after it found the company did not adequately validate its production process.

G&W Laboratories scaled up production of its Formulation R hemorrhoid ointment without studying manufacturing changes that could have affected product quality, according to an FDA warning letter.

Applicants submitting an NDA, ANDA, BLA or supplements to support parametric release for products terminally sterilized by moist heat should demonstrate the reliability of their sterilization cycle, microbiological controls, and monitoring and control of production cycle parameters, the FDA advises in a new guidance.

Shire is recalling more of its Daytrana patches for attention deficit hyperactivity disorder, possibly leading to the return of as many as 469,000 patches.

Discovery Laboratories is planning to submit its complete response to the FDA’s third Surfaxin approvable letter in September.

Watson Pharmaceuticals has recalled one lot of its 75-mcg/hour fentanyl transdermal system in the U.S. because a small number of patches were leaking the pain medicine.

Johnson & Johnson (J&J) subsidiary Ortho Biotech is recalling more than 44,000 vials of the erythropoiesis-stimulating agent Procrit because its post-manufacturing inspection found cracks in a small number of vials.

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New congressional legislation for track-and-trace drug pedigrees is unnecessary and probably will not move out of a House committee in the near future, according to an executive from the National Association of Chain Drug Stores (NACDS).

The FDA’s Center for Drug Evaluation and Research (CDER) is seeking sponsors to participate in a one-year pilot project for electronic submission and processing of clinical trial data in XML format.

In a move to speed the transition to a national electronic healthcare environment, HHS has proposed regulations to switch to the ICD-10 code set for diagnoses and to adopt the updated X12 standard, Version 5010, for electronic transactions.

The world’s top 20 pharmaceutical companies are completing their transitions from paper case report forms to electronic data capture (EDC) systems for clinical trials, according to an industry leader.