fda

  1. Gianluca

    NAC soon to be RX only?

    I already don't' see it any longer on Amazon, it looks like FDA is now trying to "regulating" it. Other website still carry it, it may be wise to stack up now. Here the article Amazon reportedly removes NAC-containing dietary supplements
  2. J

    Drug Application for Tlando Rejected Again by FDA

    Tlando is an oral form of testosterone undecanoate and failed to achieve high enough blood testosterone levels at the recommended dosage. The article says: The FDA has turned down Lipocine Inc.'s Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males...
  3. J

    FDA Denies Petition to Allow Compounding Pharmacies to Make Testosterone Pellets

    Testosterone pellets have been placed on the "difficult to compound" list, preventing compounding pharmacies from manufacturing them. A petition to reconsider this decision was denied. If I read the decision correctly, it was because proper procedure for contesting the decision was not followed...
  4. R

    FDA: New labeling requirements: More stigma for TRT Bad reporting from WebMD

    http://www.webmd.com/men/news/20161026/fda-warns-of-dangers-from-testosterone-supplements "FDA WARNS OF DANGERS FROM TESTOSTERONE SUPPLEMENTS" WebMD blares out No its not Tribulus, Horny Goat or Maca. In fact the latest fear mongering from the FDA isn't about any supplement at all don't...
  5. C

    Compounding Pharmacy FDA inspections

    I am considering going down the TRT and Trimix road, but I am concerned about compounding pharmacies and the safety of the products. I like researching things...so I found this: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm And also this...
  6. Nelson Vergel

    Defend Your Access to Compounding Products: Send the FDA your comments

    Background information: FDA compounding enforcement draws ire from Congress The FDA is asking for comments now (Deadline July 18) Please add your comments to defend the compounding industry before the FDA imposes more restrictions. They are requesting comments now...
  7. Nelson Vergel

    FDA Not Convinced that Testosterone Benefits Older Men with Low T

    Testosterone and “Age-Related Hypogonadism” — FDA Concerns August 19, 2015 Nguyen CP, Hirsch MS, Moeny D, Kaul S, Mohamoud M, et al. Testosterone and “Age-Related Hypogonadism” FDA Concerns. New England Journal of Medicine. 2015;373(8):689-91...
  8. Nelson Vergel

    The FDA uncovers who is getting a prescription of testosterone in the United States

    Note: This information only covers prescriptions paid by insurance. It does not include prescriptions from cash-basis clinics. FDA's analysis of drug utilization data for testosterone replacement therapy (TRT) over the past 5 years shows a significant increase in the use of testosterone...
  9. Nelson Vergel

    FDA rejects approval of second low T product in the past month

    As of September 17, 2014 (last FDA meeting to review requirements for testosterone studies and products), approval of testosterone replacement products has become a lot more difficult in the United States. This was fueled by two flawed studies that linked testosterone to cardiovascular risks and...
  10. Nelson Vergel

    The FDA finds drugs in weight loss supplements

    The FDA has caught several supplement companies adding medications to their weight loss supplements. Be aware that this industry is not regulated and that the FDA only does spot checks once in a while. The FDA Found Hundreds of Supplement Brands Tainted with Rx Drugs. Most Weren't Recalled.
  11. Nelson Vergel

    FDA targets illegal online pharmacies in globally coordinated action

    The U.S. Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The FDA and the U.S. Customs and Border Protection (CBP) also conducted...
  12. Nelson Vergel

    New legislation may affect compounding pharmacies and prices

    This is not a review but pertinent to this section on compounding pharmacies. A bipartisan committee of lawmakers from the Senate and the House reached a compromise on Wednesday on legislation that would give the Food and Drug Administration greater control over compounding pharmacies...
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