Standards & Regulation - BioPharm International

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Standards & Regulation

GPhA Supports Restricted Access Bill

September 18, 2014

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

European Commission Approves RoACTEMRA for Treatment of RA

September 9, 2014

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

FDA Releases Guidance Electronic Submission of Lot Distribution Reports

September 5, 2014

FDA releases draft guidance on electronic submission of lot distribution reports.

Data Integrity Key to GMP Compliance

September 1, 2014

FDA demands accurate manufacturing and test information to ensure product quality.

The Relevance of Industry Technical Associations

September 1, 2014

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

Extending the Scope of Pharmacovigilance Comes at a Price

September 1, 2014

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Case Study Interprets Continuous Process Verification Guidance

August 11, 2014

The BioPhorum Operations Group has published a resource to help the biopharmaceutical industry deliver a consistent approach to continued process verification.

Changes and Challenges for Generic Drugs

August 1, 2014

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

FDA Publishes Guidance on ANDA Submissions

July 10, 2014

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

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