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FDA grants some restrictions on ANDA and 505(b)(2) applications for salmon calcitonin nasal spray products sought by Miacalcin Nas...[ Price : $8.95]
Texas Republican Joe Barton calls for a thorough GAO study on FDAs handling of the tainted heparin issue, calling into question th...[ Price : $8.95]
Federal Register Notice: FDA releases and seeks comments on a harmonized proposal on regulatory requirements for medical devices p...[ Price : $8.95]
Federal Register Final rule: FDA removes the essential use designation for epinephrine in oral pressurized metered-dose inhalers.[ Price : $8.95]
Medtronic says it is complying with a Department of Justice subpoena for information on off-label promotion of its Infuse spinal b...[ Price : $8.95]
FDAs Anti-infective Drugs Advisory Committee says Theravances telavancin is safe and effective for complicated skin and skin struc...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Bio-Safe America, Deltex, Innovative Neurotronics, George LeMaitre, Omega Tech L...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on process validation.