美國食品藥品管理局（FDA）發布安全性警示公告稱，一項安全性臨床試驗的初步結果表明，與別嘌醇相比，抗痛風藥非布司他（febuxostat，商品名Uloric）可能增加心臟相關性死亡的風險。
- 5月 11 週四 201711:00
FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
美國食品藥品管理局（FDA）發布安全性警示公告稱，一項安全性臨床試驗的初步結果表明，與別嘌醇相比，抗痛風藥非布司他（febuxostat，商品名Uloric）可能增加心臟相關性死亡的風險。
- 9月 16 週三 201506:51
FDA Proposes Withdrawal of Low Blood Pressure Drug
Companies failed to provide evidence of clinical benefit of midodrine hydrochloride
- 6月 30 週二 201507:30
FDA Alert – Daytrana (Methylphenidate Transdermal) Linked to Permanent Skin Discoloration
Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes
ISSUE: FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. See the FDA Drug Safety Communication for photos of chemical leukoderma.
- 4月 01 週三 201520:44
[FDA Approvals]FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.
- 12月 21 週日 201400:06
FDA approves new antibacterial drug Zerbaxa(ceftolozane/tazobactam)
The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
- 2月 10 週一 201405:42
Acetaminophen, Opioids, and Safety
最近因為一些案例，讓美國重新審視Acetaminophen還有鴉片類藥物的安全性
以下是Medscape和FDA的討論：
- 1月 23 週四 201407:25
How is a medicine approved by FDA? FDA如何核准藥物的？
How is a medicine approved by FDA?
Drug companies seeking approval to sell a drug in the United States must test it. First, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in humans is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. The company then sends FDA's Center for Drug Evaluation and Research (CDER) the data from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.
Over-the-counter (OTC) drugs are regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."
- 1月 18 週六 201407:19
FDA approves first drug treatment for Peyronie’s disease
The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.
疾病介紹在這邊：
- 12月 06 週五 201305:16
[FDA Approvals]FDA Approves Macitentan for PAH
The US Food and Drug Administration (FDA) has approved macitentan (Opsumit, Actelion) to treat pulmonary arterial hypertension (PAH) in adults[1]. The approval is the second this month for the progressive, debilitating disease.
- 12月 05 週四 201304:08
[FDA Approvals]FDA Approves MitraClip for Degenerative MR
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