MDI and DPI Drug Products
...an internal reservoir containing sufficient formulation for multiple doses that are.....drug substance, optimized formulation, valve and actuator design, 89.. manufacturing process and in.....stem orifice of the valve, the vapor pressure in the container, and the nature of the..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The compatibility of the selected valve component materials with the formulation should be.....The proper performance of a metering valve should be ensured primarily by the valve manufacturer, who should assemble the valve.....The composition of the formulation of a DPI has a direct effect on the stability of the..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=86)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...The compatibility of the selected valve component materials with the formulation should be.....The proper performance of a metering valve should be ensured primarily by the valve manufacturer, who should assemble the valve.....The composition of the formulation of a DPI has a direct effect on the stability of the..
http://www.fda.gov/cder/guidance/2180dft.htm (score=86)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...Even slight changes in the formulation, drug substance particle size, valve, or actuator can have a major effect on the aerosol.....Particle size distribution is dependent on the formulation, the valve, and the mouthpiece.....The composition of an MDI formulation and the physicochemical content of each of the..
http://www.fda.gov/cder/fdama/difconc.htm (score=35)

GUIDE TO INSPECTIONS OF
...This applies to the formulation of products, as well as to the final washing of components.....If on the next day or start-up of the operation the primary valve off of the circulating.....However, for most inhalation and ophthalmic products, purified water is used in their..
http://www.fda.gov/ora/inspect_ref/igs/high.html (score=26)

10056733r03
...exposure after administration of a sirolimus oral formulation, as reflected by increases.....Tighten the rotating hemostatic valve to secure the stent delivery system to the guiding.....received the CYPHER Stent and 15 received an alternative formulation sirolimus-eluting..
http://www.fda.gov/cdrh/pdf3/P020026c.pdf (score=26)

Acidified food manufacturers
...Formulation control would have to include consideration of such things as raw material pH.....c) Is the pressure reducer valve set properly to supply correct pressure and steam flow to.....The product formulation should be developed to assure that the finished equilibrium pH is..
http://www.fda.gov/ora/inspect_ref/igs/acidfgde.htm (score=26)

OST Annual Report Section 1
...Calcification was restricted to the aortic wall component of the allograft valve conduit.....formulation of science and regulatory policy recommendations. The primary objectives are.....valve allografts. Histologic, ultrastructural, and immunostaining studies were conducted..
http://www.fda.gov/cdrh/ost/section1.html (score=26)

Premarket Approval Decisions September 1999
...Approval for a change in the bone cement formulation to alter the handling characteristics.....Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to.....Medtronic Hall Prosthetic Heart Valve, Models A7700 and M7700, Aortic Valved Conduit..
http://www.fda.gov/cdrh/pma/pmasep99.html (score=26)

...The intent is to insure that the batch was, in fact, produced according to the approved.....b) Microprocessors can be used for controlling a steam valve, maintaining pH, etc. They.....formulation. Consider what might happen when three lots of a component are used with a..
http://www.fda.gov/ora/inspect_ref/igs/csd.html (score=25)

GUIDE TO INSPECTIONS OF LYOPHILIZATION OF PARENTERALS
...When this valve is closed the chamber is isolated from the external condenser. Also known.....the formulation of solutions; filling of vials and validation of the filling operation.....UNLOADING VALVE.. This valve connects the interstage with suction to equalize both pressures during..
http://www.fda.gov/ora/inspect_ref/igs/lyophi.html (score=25)

PMA Final Decisions Rendered for October 2002
...Approval for the Omnicarbon Cardiac Valve Prosthesis in the additional size of 21 mm of.....Valve and will be given the model designation of Model ONXAC and is indicated for.....Approval for a modification to the formulation of Carisolv. P000018/S021.. 10/25/02.. Real..
http://www.fda.gov/cdrh/pma/pmaoct02.html (score=25)

Premarket Approval Decisions for November 2001
...Approval for relocation of the formulation of the bulk past and the equipment and.....The Hall Easy-Fit™ Prosthetic heart Valve is a modification of the approved Medtronic Hall.....Valve; the modification consisting of a new sewing cuff material and design, intended for..
http://www.fda.gov/cdrh/pma/pmanov01.html (score=25)

Saline, Silicone Gel, and Alternative Breast Implants - Draft Guidance for...
...Valve competence tests are performed to demonstrate that valve integrity is maintained at.....viscosity, molecular weight) the formulation of the polymer (the ratio of polymer should.....However, this methodology may provide useful information about the valve handling shifts..
http://www.fda.gov/cdrh/ode/guidance/1239.html (score=25)

PMA Final Decisions Rendered for November 1997
...The device is a tissue heart valve and is indicated for the replacement of malfunctioning.....Approval for new PMMA/MMA-Styrene co-polymer formulation. The device, as modified, will be.....This device is a replacement heart valve and is indicated for the replacement of..
http://www.fda.gov/cdrh/pmanov97.html (score=25)

OFFICE OF DEVICE EVALUATION - Annual Report Fy 2001
...The new formulation allows the dentist to apply the gel without mixing and therefore.....on August 15, 2001 to reclassify the Endolymphatic Shunt Tube with Valve from Class III.....formulation. DDIGD evaluated submissions during the fiscal year on liquid chemical agents..
http://www.fda.gov/cdrh/annual/fy2001/ode/annualreport2001.html (score=25)

Packaging
...Complete construction, composition, and description of all component parts of valve closure and container, including valve.....The identity of the source and a description of the formulation(s), process(es), and.....When drugs are administered by means of an aerosol dosage form, the valve closure system..
http://www.fda.gov/cder/guidance/package.htm (score=25)

PMA Final Decisions Rendered for February 1995
...APPROVAL TO UTILIZE 02/16/95 PROSTHETIC HEART NEW STEAM STERILIZER VALVE AUSTIN, TX AND AN.....FORMULATION 02/23/95 SENSITIVE EYES ADJUSTMENT TO ENHANCE LENS LUBRICANT ROCHESTER, NY THE.....PAUL, MN SHEET REGARDING THE 55117 ORIENTATION OF THE VALVE IN THE VALVE HOLDER. P810031/S18 HEALON..
http://www.fda.gov/cdrh/pmafeb95.html (score=25)

Updates--November-December 1997 FDA Consumer
...The evidence comes from doctors who performed echocardiography to evaluate heart valve.....formulation had failed. The public has until Nov. 13 to send written comments on the rule.....valve problems, the manufacturers have withdrawn the obesity drugs from the market at FDA..
http://www.fda.gov/fdac/departs/1997/797_upd.html (score=25)

Updates--March-April 1998 FDA Consumer
...Toronto SPV Valve is a new type of heart valve for adults with defective natural or.....Fortovase (saquinavir) is a new formulation of a protease inhibitor for treatment of HIV.....Also, echocardiograms showed no more valve disease in patients on Meridia than those on..
http://www.fda.gov/fdac/departs/1998/298_upd.html (score=24)

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