Statement from FDA Commissioner Scott Gottlieb, M.D., on newsteps to advance medical device innovation and help patients gain faster access to beneficial technologies

Statement from FDA Commissioner Scott Gottlieb, M.D., on newsteps to advance medical device innovation and help patients gain faster access to beneficial technologies

Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation. Continue reading.
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FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues

FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues

Today the U.S. Food and Drug Administration issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results. Continue reading.

Phytomenadione, Phytonadione, фитоменадион ,فيتوميناديون ,

New Drug Approvals

Vitamin K1.png

ChemSpider 2D Image | Phylloquinone | C31H46O2

Phytomenadione,

PHYTONADIONE, Phylloquinone

Molecular Formula: C31H46O2
Molecular Weight: 450.707 g/mol
[R-[R*,R*-(E)]]-2-Methyl-3-(3,7,11,15-tetramethyl-2-hexadecenyl)-1,4-naphthalenedione
1,4-Naphthalenedione, 2-methyl-3-((2E,7R,11R)-3,7,11,15-tetramethyl-2-hexadecenyl)-
2′,3′-trans-Vitamin K1
фитоменадион [Russian] [INN]
فيتوميناديون [Arabic] [INN]
2-methyl-3-[(2E,7R,11R)-3,7,11,15-tetramethylhexadec-2-en-1-yl]naphthalene-1,4-dione
 CAS 84-80-0[RN]
Antihemorrhagic vitamin
Aqua mephyton
AQUAMEPHYTON
Combinal K1
Kativ N
Kephton
Kinadion
K-Ject
KONAKION
Mono-kay
Phyllochinonum
Phylloquinone (8CI)
Optical Rotatory Power -0.28 ° Solv: 1,4-dioxane (123-91-1); Wavlen: 589.3 nm; Temp: 25 °CKarrer, P.; Helvetica Chimica Acta 1944, VOL 27, PG317-19

MASS

1H NMR

400 MHZ CDCL3

13C NMR

  1. Murahashi, Shun-ichi; European Journal of Organic Chemistry 2011, VOL2011(27), P5355-5365 
  2. Huang, Zhihong; Advanced Synthesis & Catalysis 2007, VOL349(4+5), PG539-545 

IR LIQ FILM

Phylloquinone is a family of phylloquinones that contains a ring of 2-methyl-1,4-naphthoquinone and an isoprenoid side chain. Members of this group of vitamin K 1 have only one double bond on the proximal isoprene unit. Rich sources of vitamin K 1 include green plants, algae, and photosynthetic…

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