Sentence examples for guidance documents issued from inspiring English sources
All relevant methodological requirements and procedural aspects regarding HTA are laid down in guidance documents issued by NICE.
Regulatory guidance regarding JAS is available from The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M3 R2) guideline and from more specific guidance documents issued by the Food and Drug Administration FDAas as well as the European Medicines Agency EMAA).
A few FDA guidance documents issued were specific to drug substance, e.g., Bulk Active Compound Post-approval Change (BACPAC) 1, but have since been withdrawn.
Models estimating exposure from the use of household products, have been outlined in guidance documents issued by the European Commission for assessing exposure for chemicals and biocidal active substances [ 11, 12], and also in the HERA Guidance Document [ 13].
As discussed in guidance documents issued by the American Association for the Study of Liver Diseases (AASLD) 19 and the European Association for the Study of the Liver, 20 this regimen represents an important option for treatment-experienced patients who are able to tolerate 12 weeks of peg-IFN therapy, particularly those with compensated cirrhosis.
We focused on these four diseases because surrogate outcomes (lung function parameters for COPD, blood sugar level for diabetes, intraocular pressure (IOP) for glaucoma and bone mineral density for osteoporosis, respectively) are commonly used as primary outcomes in RCTs and all of them are 'well established' surrogates according to the guidance documents issued by the FDA.
Under a draft guidance document issued the same day as the letter, the agency plans to release crucial information that it previously withheld.
For proof, you need look no further than the Pentagon's new "strategic guidance" document, issued last month in the wake of Mr. Obama's pledge to cut $485 billion from the defense budget over the coming decade.
Table 2 Summary of FDA guidance document issued in 2013 and potential issues in implementation FDA guidance 2013 Potential issues Definitions of ABSSSI Cellulitisis or erysipelas, wound infections, and abscesses with at least 75 cm2 area of redness, edema, or induration.
In an "industry guidance" document it issued in 2001, the commission said that in deciding whether to punish a broadcaster with fines or license revocations, it would consider "whether the material dwells on or repeats at length descriptions of sexual or excretory organs or activities".
