Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe
Inside Standards
Standards-Setting Activities on Impurities
January 2, 2013
USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
Inside USP: US Pharmacopeia Proposes New Standard on Glass Quality
June 2, 2012
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.
Inside PIC/S: Top GMP Deficiencies
April 2, 2012
Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.
Inside USP: A Holistic Approach to Supply-Chain Integrity
March 2, 2012
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.
Inside ICH: ICH Implementation Support
February 2, 2012
ICH Q8, Q9, and Q10 support and implications for the future.
FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy
FDA seeks preliminary injunction against New York fish manufacturer
FDA approves Simponi to treat ulcerative colitis
FDA approves new drug for advanced prostate cancer
FDA approves Nymalize--first nimodipine oral solution for use in certain brain hemorrhage patients

Last updated on Sat May 18 14:32:00 EDT 2013

Standards & Regulations
Regulatory Convergence Sought for Global Pharma Market
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
Regulatory Roundup
FDA faces budget crunch; Supreme Court hears key cases
Should Regulation of Combination Products Become More Centralized in Europe?
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
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