1. Articles from fda.gov

  2. 1-15 of 15
    1. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

      FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

      The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.

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    2. The FDA has released a leap-frog guidance on 3D printed devices:

      The FDA has released a leap-frog guidance on 3D printed devices:

      The FDA has released a leap-frog guidance on 3D printed devices:  "Technical Considerations for Additive Manufactured Devices

      This draft guidance is a leap-frog guidance; leap frog guidances are intended to serve as a  mechanism by which the Agency can share initial thoughts regarding emerging technologies  that are likely to be of public health importance early in product development. This leap-frog  guidance represents the Agency's initial thinking, and our recommendations may change as more information becomes available.

      Biocom San Diego Releases Strategic Plan to 2020

      The plan outlines the following objectives:

      • The plan expects to see San Diego as the recognized global leader in genomics. 
      • The leading US portal to Japan life science companies
      • Home of the world’s largest, most diverse CRO industry
      • A cohesive Southern California life sciences market

      Download the complete plan here.

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      Mentions: Japan FDA San Diego
    3. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

      Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff Document issued on: March 17, 2015
      This document supersedes: “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidanc e/GuidanceDocuments/UCM080268.pdf ) issued April 1996.

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      Mentions: Jorg Lorscheider
    4. Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

      Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

      Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act).  Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices. This regulation became effective on December 18, 1978, and was codified under part 820.

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    5. Hearing Aids

      Hearing Aids

      Having trouble hearing? Over 35 million children and adults in the United States have some degree of hearing loss. Hearing loss can have a negative effect on communication, relationships, school/work performance, and emotional well-being. However, hearing loss doesn't have to restrict your daily activities. Properly fitted hearing aids and aural rehabilitation techniques can help in many listening situations. Aural rehabilitation helps a person focus on adjusting to their hearing loss and the use of their hearing aids. It also explores assistive devices to help improve communication. Hearing aids for both ears are typically the norm for most hearing impaired people, but some may need only one hearing aid.

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      Mentions: FDA
    6. FDA Announcement = Phenylpropanolamine (PPA) Information Page

      The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. In addition, FDA has issued a public health advisory concerning phenylpropanolamine. This drug is an ingredient that was used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.
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    7. Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient

      ISSUE: Lab analysis has found Duro Extend Capsules for Men to contain Sulfoaidenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction, making the product an unapproved drug. The analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
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      Mentions: FDA
    8. Infant Overdose Risk With Liquid Vitamin D

      Infant Overdose Risk With Liquid Vitamin D
      The Food and Drug Administration (FDA) is warning of the potential risk of overdosing infants with liquid vitamin D. Some liquid vitamin D supplement products on the market come with droppers that could allow parents and caregivers to accidentally give harmful amounts of the vitamin to an infant. These droppers can hold a greater amount of liquid vitamin D than an infant should receive.
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    9. FDA recall of Atlas Operation DIetary Supplements

      Atlas Operations, Inc. Recalls Many Sexual Enhancement Products (FDA; 12/15/2009)Atlas Operations, Inc. and FDA notified consumers of a nationwide recall of the company's dietary supplements for sexual enhancement. These products are currently being sold as dietary supplements throughout the United States. FDA lab analyses found that the products tested from certain batches contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making these products unapproved drugs. The active drug ingredient is not listed on the product labels.
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      Mentions: FDA
    1-15 of 15
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