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Public Meeting on Opioid Abuse-deterrent Properties

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Federal Register Notice: FDA announces a 10/31 to 11/1 public meeting in College Park, MD to discuss scientific and technical issu...

Final Rule on 505(b)(2), ANDA Patent Certifications

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Federal Register Final Rule: FDA issues a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Mod...

Data Monitoring Committees Need Flexibility: Study

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Researchers say that data monitoring committees have complex responsibilities and may have to cope with unexpected developments du...

Big Changes to Waxman-Hatch Regs Outlined

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Attorney Kurt Karst says a new FDA final rule will forever alter the Waxman-Hatch landscape and will likely fuel controversies and...

Novartis Settles Elidel False Claims Case

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Novartis pays over $35 million to settle a whistleblowers claims that it marketed Elidel for off-label use in infants and violated...

Nurse Assist Recalls I.V. Flush Syringes

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Nurse Assist recalls all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infecti...

FDA Breakthrough Designation for Actemra/RoActemra

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FDA grants Roches Actemra/RoActemra Breakthrough Therapy designation for giant cell arteritis.

FDA Grants Breakthrough Status for Chugai Drug

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FDA grants Chugai Pharmaceutical a breakthrough therapy designation for Actemra /RoActemra (tocilizumab), a Chugai-originated drug...

Tropical Disease Voucher Guidance Out

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FDA issues a guidance interpreting implementing provisions of the law authorizing it to award priority review vouchers for certain...

FDA Guidance on Developing Drugs for Treating Lice Infestation

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FDA posts a guidance on Head Lice Infestation: Developing Drugs for Topical Treatment to assist sponsors in the clinical developme...