Search results for " name"
Article
Supplier-Change Management for Drug-Product Manufacturers
…turing, testing, and warehousing among others)
• Change in ownership
• Change in company name
• Use of a new subcontractor for purchased materials or services
• Change in certificatio…
Article
Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
However, the grounds for European refusal was not scientific in nature, but was due to the existence of a 10-year marketing exclusivity granted to a substantially similar product (trade name Vpriv), a…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Priority 3 of that plan focuses on product manufacturing and quality, including enabling the development and evaluation of novel and improved manufacturing methods to improve product quality, namely t…
Resource
The Pharmaceutical Manufacturers Association
Its name was changed to the Pharmaceutical Research and Manufacturers of America in 1994. Headquartered in Washington, DC, PhRMA represents the country’s leading pharmaceutical research and biotechnol…