Literature DB >> 10249526

Content and format for labeling for human prescription drugs; amendment of effective date for certain biological products--Food and Drug Administration. Final rule.

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Abstract

The Food and Drug Administration (FDA) amends the effective date of its regulations designating a required content and format for the professional labeling of certain biological products for human use. FDA is taking this action to reduce the burden of the regulations on manufacturers of certain biological products licensed after July 1, 1972.

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Year:  1981        PMID: 10249526

Source DB:  PubMed          Journal:  Fed Regist        ISSN: 0097-6326


  4 in total

Review 1.  Asthma treatment during pregnancy. What can be safely taken?

Authors:  M Schatz
Journal:  Drug Saf       Date:  1997-05       Impact factor: 5.606

Review 2.  Inclusion of pregnant and breastfeeding women in research - efforts and initiatives.

Authors:  Sílvia M Illamola; Christina Bucci-Rechtweg; Maged M Costantine; Ekaterini Tsilou; Catherine M Sherwin; Anne Zajicek
Journal:  Br J Clin Pharmacol       Date:  2017-10-22       Impact factor: 4.335

3.  Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation.

Authors:  Blanca Arguello; Teresa M Salgado; Fernando Fernandez-Llimos
Journal:  Br J Clin Pharmacol       Date:  2015-03       Impact factor: 4.335

Review 4.  Mood stabilizers in pregnancy and lactation.

Authors:  Sandeep Grover; Ajit Avasthi
Journal:  Indian J Psychiatry       Date:  2015-07       Impact factor: 1.759

  4 in total

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