Standards/Regulations

Feb 01, 2018
The President described US drug costs as unfair and stated that prices will come down.
Jan 31, 2018
FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.
Jan 24, 2018
By BioPharm International Editors
The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.
Jan 23, 2018
By BioPharm International Editors
The FDA center released its list of planned guidance documents for the rest of the year.
Dec 05, 2017
By BioPharm International Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Nov 27, 2017
Manufacturers and trading partners struggle to meet drug tracking requirements
Nov 16, 2017
By BioPharm International Editors
Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.
Nov 10, 2017
By BioPharm International Editors
Two of the medicines recommended for approval are orphan drugs.
Nov 07, 2017
By BioPharm International Editors
While most pharma companies are in partial production using generators, few are operating at 100% capacity.
Nov 07, 2017
By BioPharm International Editors
The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.
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