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Medtronic recently announced the launch of its Restore Rechargeable Neurostimulation System for people suffering from chronic pain. FDA approved the device earlier this month.
The FDA may start taking a closer look at the use of electronic patient diaries and electronic data capture in clinical trials from a compliance standpoint, an industry expert predicted recently.
A coalition of eight pharmaceutical companies is gearing up a public relations campaign for the SAFE (Secure Access for Everyone) digital signature standard that will culminate in major announcements at the Drug Information Association’s annual meeting in June, a coalition spokesman told DID.
PhRMA launched an enhanced and expanded version of its biopharmaceutical innovation website April 14 — part of its ongoing efforts to better educate the public about the industry’s drug-development efforts.
Roche has launched a public clinical trials registry and results database, the company announced April 15. Thomson CenterWatch, a Boston data management company, is hosting the site for Roche, which is based in Basel, Switzerland.
Medicare should quickly adopt a comprehensive electronic prescribing system based on a technologically advanced uniform national standard to realize the full benefits of eprescribing under the new Medicare prescription drug benefit, the Pharmaceutical Care Management Association (PCMA) told the Centers for Medicare & Medicaid Services (CMS).
A powerful Republican senator has asked drug industry leaders to help push through the confirmation of Lester Crawford as permanent FDA commissioner — a plea that follows a move by two Senate Democrats to block the confirmation vote until a decision is made on approving the OTC status of Plan B, an emergency contraceptive.
The FDA may start taking a closer look at the use of electronic patient diaries and electronic data capture in clinical trials from a compliance standpoint, an industry expert predicted recently.
Sentrx has completed an FDA electronic submissions pilot and has begun sending individual case safety reports (ICSRs) from a leading pharmaceutical company to the agency through the Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway, the technology company announced April 4.
Canon shareholders approved an expansion to the company’s articles of incorporation March 30 to include the commercialization of DNA chips, classified under “production and sale of pharmaceutical products,” as a way for Canon to enter the biotechnology field.