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FDA recently issued its highly anticipated guidance regarding new dietary ingredient (NDI) notifications, and several aspects have prompted substantial industry objection and concern. Most would agree that the agency thinking, as captured in the guidance document, will impose an increased burden on supplement companies seeking to comply with applicable regulations.
FDA has amended the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food … [Read More...]
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the … [Read More...]
FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are about 50 such guidances planned. Below are … [Read More...]
ADPEN brings aboard Agilent’s newest Triple Quadrupole LC-MS/MS, the 6490 with iFunnel technology. The 6490 has unprecedented sensitivity and is today’s most sensitive triple quadrupole mass spectrometer. It is designed to deliver high levels of sensitivity and robustness for even the most complex and demanding matrices. ADPEN has interfaced the 6490 with Agilent’s latest 1290 [...]
FDA- What’s New: Drugs