FDA adds three questions and answers to the laboratory controls section of a guidance on current good manufacturing practices.
PhRMA makes general and detailed recommendations for changes to an FDA draft guidance on continuous manufacturing quality considerations.
Federal Register notice: FDA seeks comments on an information collection revision for Protection of Human Subjects; Informed Consent; and Institutiona...
FDA approves Pretomanid to be used in combination with two other drugs to treat a limited and specific population of adult patients with extensively d...
FDA issues Dr. Reddys Laboratories two complete response letters for generic copies of Tevas multiple sclerosis drug Copaxone (glatiramer acetate inje...
Federal Register notice of intent: FDA announces its intention to begin inactivating drug listing records that are improperly listed.
Rep. Cummings and Sen. Sanders ask three generic drug companies for pricing information and say the companies appear to have coordinated responses to ...
FDA clears Pollogens radiofrequency home-use device TriPollar Stop for treating the face and the neck to eliminate aging signs and reduce lines and wr...