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 •  June 27

As part of its effort to increase competition in the prescription drug market, the FDA released a list of drugs that are off-patent and off-exclusivity without approved generics and produced a revised manual of policies and procedures for review of abbreviated new drug applications, including prioritization for generic products. “No patient should...

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 •  April 28

DESTIN, Fla. — Despite the challenges of drug development for the treatment of systemic lupus erythematosus, there are reasons for optimism about the future, according to a speaker at the Congress of Clinical Rheumatology Annual Meeting. “It has not all been about failure. We have had some success. There have been four – BLISS-52, BLISS-76,...

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 •  March 13

By Theresa Toigo, MBA, RPh, and Cynthia LaCivita, PharmD When prescribing or dispensing a drug, clinicians may be required to take specific safety steps prior to the patient receiving the medication. These measures may be part of an FDA–required safety program called Risk Evaluation and Mitigation Strategies (REMS). REMS programs are FDA–required...