Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1998 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
No grāmatas satura
1.–5. rezultāts no 100.
4. lappuse
... drug products for over - the- counter human use 238 340 Stimulant drug products for over - the - counter human use 239 341 344 346 Cold , cough , allergy , bronchodilator , and anti- asthmatic drug products for over - the - counter ...
... drug products for over - the- counter human use 238 340 Stimulant drug products for over - the - counter human use 239 341 344 346 Cold , cough , allergy , bronchodilator , and anti- asthmatic drug products for over - the - counter ...
8. lappuse
... Drugs or Devices 310.500 Digoxin products for oral use ; condi- tions for marketing . 310.501 Patient package inserts for oral con- traceptives . 310.502 Certain drugs accorded new drug sta- tus through rulemaking procedures . 310.503 ...
... Drugs or Devices 310.500 Digoxin products for oral use ; condi- tions for marketing . 310.501 Patient package inserts for oral con- traceptives . 310.502 Certain drugs accorded new drug sta- tus through rulemaking procedures . 310.503 ...
10. lappuse
... products subject to license control . ( a ) Except for radioactive biological products intended for human use , a new drug shall not be deemed to be subject to section 505 of the act if it is a drug licensed under the Public Health ...
... products subject to license control . ( a ) Except for radioactive biological products intended for human use , a new drug shall not be deemed to be subject to section 505 of the act if it is a drug licensed under the Public Health ...
21. lappuse
... drug experiences on marketed prescription drugs for human use without approved new drug applications . ( a ) Scope . FDA is requiring manufac- turers , packers , and distributors of marketed prescription drug products that are not the ...
... drug experiences on marketed prescription drugs for human use without approved new drug applications . ( a ) Scope . FDA is requiring manufac- turers , packers , and distributors of marketed prescription drug products that are not the ...
22. lappuse
... product as its manufac- turer , packer , or distributor shall re- port to FDA each adverse drug experi- ence received or otherwise obtained that is both serious and unexpected as soon as possible , but in no case later than 15 calendar ...
... product as its manufac- turer , packer , or distributor shall re- port to FDA each adverse drug experi- ence received or otherwise obtained that is both serious and unexpected as soon as possible , but in no case later than 15 calendar ...
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Bieži izmantoti vārdi un frāzes
abbre abbreviated application abbreviated new drug acid active ingredient adverse drug experience agency amended antibiotic application or abbreviated bacitracin bioavailability bioequivalence cation Center for Drug certification chapter clinical hold clinical investigation conducted control number copy Cosmetic Act digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing drug substance Evaluation and Research Federal Food Food and Drug graph gredients hearing hydrochloride identified information requirements ap insulin intended inves investigational new drug labeling manufacturer marketing meet ment milligrams milliliters misbranded neomycin notice oral dosage orphan drug OTC drug product package paragraph percent person plication polymyxin proposed protocol recognized as safe reference listed drug request safe and effective safety section 502 Sodium sponsor statement submission Subpart sulfate tained tigational tion tive treatment treatment IND vestigational viated warning