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FDA approves treatment for sexual dysfunction in premenopausal women
The FDA has announced its approval of a therapy for hypoactive sexual desire disorder in premenopausal women.
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Food and Drug Administration
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FDA plans to institutionalise drug compounding
The FDA has told its staff that it will be assigning drug compounding to the Office of Compliance.
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Premier Pharmacy Labs recalls products after FDA inspection
The company has announced a recall of products which were intended to be sterile after a lack of sterility assurance.
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FDA announces new data points to aid generic drug developers
The FDA has released new data points which increase transparency for generic-drug competitors.
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First treatment for cluster headaches approved in US
The FDA has given its approval to a new injection for cluster headaches which reduce frequency of attacks.
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Pharma to benefit from FDA digital health regulations
Companies that invest heavily now stand to steal a lasting lead over rivals that hesitate...
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FDA steps up action to ensure quality of compound drugs
The FDA is seeking closer collaboration with state authorities to ensure the quality of compounded drugs and the public’s access to them...
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How the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes
This article explores how the new draft of Annex 1, Manufacture of Sterile Medicinal Products impacts environmental monitoring programmes.
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Antibiotic for skin condition granted Priority Review by FDA
The US FDA have granted the NDA for iclaprim, an antibiotic for a skin condition, Priority Review, with a decision date set for February 2019...
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Boosting the safety of bulk drug substances is aim of FDA measures
Boosting the safety of compounded drugs is the aim of new plan from the US Food and Drug Administration (FDA), which has unveiled a series of measures.
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Flare-responsive hydrogel developed to treat arthritis
Researchers develop a better delivery system for anti-inflammatory therapies...
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Smart bandage could promote better, faster healing
Researchers have collaborated to design a smart bandage that could eventually heal chronic wounds...
