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May 17, 2018
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
Internationalization and regulatory reform are driving growth and investment China.
February 08, 2018
Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.
February 02, 2018
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
January 25, 2018
Growth is expected for the generic drugs and biosimilars sectors, driven by cost pressures on healthcare systems.
January 19, 2018
Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.
January 16, 2018
The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.
January 03, 2018
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
December 05, 2017
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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
December 02, 2017
The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.