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The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) updated its pharmaceutical marketing practice code, creating tougher restrictions on the gifts healthcare professionals can receive, the organization announced.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) updated its pharmaceutical marketing practice code, creating tougher restrictions on the gifts healthcare professionals can receive, the organization announced.
Sens. Chris Dodd (D-Conn.) and Mike DeWine (R-Ohio) introduced a bill to promote the development and use of medical devices designed for young children so physicians have choices over “one-size-fits-all” products.
Citing an increasing number of requests to conduct global clinical trials in India and the desire to "ensure that the Indian entrepreneurs grab this opportunity," India's Office of Drug Controller General (DCG) has outlined new procedures for handling clinical trial applications.
Sponsors planning clinical trials in foreign countries must learn about and follow local laws and regulations, said experts speaking at Public Responsibility in Medicine and Research’s Annual Human Research Protection Programs Conference last month.
A key goal of GMP training is to bring employees up to a satisfactory level of competence that can be proven to FDA inspectors, according to David Markovitz, president and founder of GMP Training Systems, who spoke at an FDAnews audioconference last month. Read More
The FDA intends to issue a proposed rule on current good manufacturing practices (cGMPs) for combination products next spring, a senior FDA official said at the Regulatory Affairs Professionals Society annual conference last month. Read More
Tissue-engineered products "containing or made exclusively of nonviable human or animal tissues and/or cells, which do not act principally by pharmacological, immunological or metabolic action" would not be regulated as advanced therapy medicinal products (ATMPs) under the latest version of the European Commission's proposed ATMP regulation. Read More