Standards/Regulations

Aug 08, 2017
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Aug 01, 2017
BioPharm International
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
Aug 01, 2017
By BioPharm International Editors
The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.
Aug 01, 2017
By BioPharm International Editors
The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.
Jul 28, 2017
Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.
Jul 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
Jul 25, 2017
By BioPharm International Editors
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Jul 25, 2017
By BioPharm International Editors
The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
Jul 21, 2017
By BioPharm International Editors
The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.
Jul 21, 2017
By BioPharm International Editors
The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.
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