Regulatory

May 02, 2018
From BioPharm International
Public health authorities and the biomedical research community are seeking new strategies to address global health threats, writes Jill Wechsler.
Apr 26, 2018
Pharmaceutical Executive
Prashant Dhanavade discusses the impact, challenges and the importance of ensuring readiness with ICH E2B (R3) EudraVigilance.
Apr 04, 2018
FDA is moving slowly in liberalizing off-label communications amid outrage over opioid promotion. Jill Wechsler reports.
Mar 29, 2018
After months of delay, Congress finally passed a $1.3 trillion omnibus budget bill March 22, 2018, just in time to avoid another government shut-down.
Mar 08, 2018
As part of FDA initiatives to reward innovation and promote patient access to medicines, the agency is working hard to support the development of high quality biosimilars and interchangeable products, Scott Gottlieb told a conference on March 7.
Mar 07, 2018
Pharmaceutical Executive
The public and policymakers seek more transparency in pricing and product development.
Feb 26, 2018
Adhering to new compliance legislation such as Identification of Medicinal Products (IDMP) can bring a pharma company benefits as well as challenges, writes Darren Cooper.
Feb 14, 2018
Advocates on all sides applauded the request to increase funding significantly for FDA under the Trump administration’s budget for fiscal year 2019.
Feb 08, 2018
Commissioner Scott Gottlieb this week outlined FDA plans to continue the fight against opioid addiction and to prepare a “comprehensive plan” to bolster the market for biosimilars.
Feb 06, 2018
Pharmaceutical Executive
Low-cost follow-ons and biosimilars please payers but heighten competitive battles with brands.
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