Monday, November 16, 2015
In a recent study, only two-thirds of clinical trials per drug that supported new drug approvals in 2012 were disclosed, falling below legal and ethical standards.
Legislation sponsored by Assembly Democrats of the New Jersey General Assembly (Pamela Lampitt, Daniel Benson, Shavonda Sumter, Nancy Pinkin, and Herb Conaway Jr., M.D.) to make it easier for consumers to obtain more cost-effective, “generic” versions of biological medicines used to treat conditions such as rheumatoid arthritis, anemia, psoriasis and various forms of cancer has been signed into law.
Democrats in the U.S. House have formed an Affordable Drug Pricing Task Force to tackle meaningful action to combat the skyrocketing costs of pharmaceuticals.
Veeva Systems, a cloud-based software provider for the global life sciences industry, has launched Veeva Vault RIM, a next-generation regulatory information management (RIM) suite. Vault RIM unites submission documents, published dossiers, product registrations and health authority interactions into a single authoritative source for all regulatory information. The convergence of RIM capabilities in Veeva Vault’s regulatory product suite will align disconnected regulatory processes worldwide, dramatically improving life sciences companies’ speed, agility and compliance.
Although shorter informed consents, greater use of central IRBs and broader biospecimen consent for unspecified future research were among the possible changes outlined by the Department of Health and Human Services (HHS) in its recent notice of proposed rulemaking for human subject research protections, not all IRBs are fully on board.