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© 2021 MJH Life Sciences and Pharmaceutical Executive. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Executive. All rights reserved.
April 16, 2021
FDA is halting enforcement of a policy that limits prescribing and dispensing of Mifeprex (mifepristone), a widely used drug to induce a medical abortion in the very early stages of pregnancy.
April 14, 2021
FDA acting commissioner Janet Woodcock announced this week that Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research (CDER), shifting from her role as acting director since last spring.
Life sciences companies uniquely tasked with meeting continuous and complex compliance-reporting requirements.
April 09, 2021
A picture of wide manufacturing violations appears in a recently disclosed FDA form 483 report on a site visit to Emergent’s Baltimore vaccine plant.
April 08, 2021
Updated programs supporting the development and review of prescription medicines are being readied for approval by federal agencies and ultimately by Congress
April 02, 2021
New American Jobs Plan set to be funded by corporate taxes will affect biopharma industry.
March 29, 2021
With Sen. Bernie Sanders leading the charge on Capitol Hill, the campaign to limit U.S. outlays for prescription drugs has accelerated.
March 24, 2021
FDA is reviewing the record of its accelerated approval program following recent withdrawals of certain key indications for several leading cancer therapies, based on the failure of post-approval studies to document extended benefits of treatment.
Pharma and life science companies can reduce time to market by optimizing regulatory content management and submission processes.
March 23, 2021
Assessing the implications for the pharma industry of the America Rescue Plan Act of 2021, which provides nearly two trillion dollars in funding for various government programs, including many related to public health.