Regulatory/GMP Compliance

Jun 01, 2018
BioPharm International
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
Jun 01, 2018
BioPharm International
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
May 31, 2018
By BioPharm International Editors
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
May 30, 2018
By BioPharm International Editors
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
May 29, 2018
By BioPharm International Editors
This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.
May 23, 2018
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
May 17, 2018
By BioPharm International Editors
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
May 14, 2018
By BioPharm International Editors
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 11, 2018
The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
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