Regulatory/GMP Compliance

May 30, 2018
By Pharmaceutical Technology Editors
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
May 29, 2018
By Pharmaceutical Technology Editors
This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.
May 23, 2018
By Pharmaceutical Technology Editors
The agency issued guidance on over-the-counter topical drug products that address maximal usage trials.
May 23, 2018
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
May 17, 2018
By Pharmaceutical Technology Editors
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
May 15, 2018
Pharmaceutical Technology
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
May 15, 2018
Pharmaceutical Technology
ASTM’s E-55.05 committee aims to turn best practices into industry standards in order to eliminate variability and allow a 70-year-old process to leverage 21st century tools, technologies, and practices.
May 14, 2018
By Pharmaceutical Technology 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 10, 2018
By Pharmaceutical Technology Editors
The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
native1_300x100
lorem ipsum