• Could Radiation Exposure Recommendations Affect an Impending App Guidance?

    The US Food and Drug Administration (FDA) may be in the midst of increasing cellphone use by developing its mobile medical application guidelines, but at least one government agency and a US legislator are calling for additional research on the effects of radiation emitted from the phones themselves. In a 24 July report released by the Government Accountability Office (GAO), the government's internal program watchdog, the agency said a reassessment of the effects of ra...
  • FDA Releases Adverse Event Guidance for Small Businesses

    The US Food and Drug Administration (FDA) wants to help small businesses comply with regulations pertaining to adverse event reporting. In 2008, the agency released a new regulation directing all companies to include a hotline number for FDA's adverse event reporting service, which collects information about safety issues. The number must coincide with an explanation of what the number is, and that it is not intended for dispensing medical advice. In its 14 June guidanc...
  • FDA Seeks to Standardize CDER's Telephone Availability

    A new manual of policies and procedures (MAPP) released by the US Food and Drug Administration's (FDA) Office of Management (OoM) dictates how the Center for Drug Evaluation and Research (CDER) must maintain adequate and consistent phone coverage to allow regulatory professionals and the public to reach the agency during normal business hours. "As Federal employees and public servants, CDER employees must be responsive to the needs of the public," writes OoM. "The public...