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Pharmaceutical and Device
India’s Device Manufacturers to Receive Their Own Marketing Guidelines
In mid-March 2022, the Department of Pharmaceuticals (DoP) in India published a draft Uniform Code for Medical Device Marketing…
PhRMA Announces Updated Code on Interactions with Health Care Professionals…
On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) released its updated Code on Interactions with…
Groups File Amicus Brief in Support of North Dakota’s Efforts to Regulate…
Recently, the Alliance for Transparent & Affordable Prescriptions (ATAP), the Community Oncology Alliance (COA), and American…
FDA Approves New Alzheimer’s Drug
On June 7, FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway,…
PhRMA Files Petition to Stop New Mexico Drug Importation Plan
On March 18, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA), along with the Partnership for Safe Medicines…
FDA Meets All Goal Dates for 2020 Drug Approvals
In 2020, the United States Food and Drug Administration (FDA) not only met all goal dates for approvals by the Center for Drug…
Drug Manufacturers Sue HHS Over 340B Advisory Opinion
Three drug companies have filed separate lawsuits to preserve their ability to restrict offerings of 340B-discounted drugs to…
PhRMA Sues Over “Unconstitutional” 340B Rule
In late January, the Pharmaceutical Research and Manufacturers of America (PhRMA) sued the United States Department of Health and…
PhRMA Announces Principles on Clinical Trial Diversity
Late last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced new industry-wide Principles on Conduct…
PhRMA Files Motion for Restraining Order and Preliminary Injunction in MFN…
On December 10, 2020, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Association of Community Cancer…