The US FDA pregnancy lactation and labeling rule - Implications for maternal immunization

Vaccine

Volumn 33, Issue 47, 2015, Pages 6499-6500

  Gruber, Marion F ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Maternal immunization; Pregnancy; Vaccines

Indexed keywords

BIOLOGICAL PRODUCT; PRESCRIPTION DRUG; VACCINE;

ARTICLE; DRUG PACKAGING; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNIZATION; INFORMATION; LACTATION; MATERNAL IMMUNIZATION; PREGNANCY; PRIORITY JOURNAL; RISK; UNITED STATES; VACCINATION; ADVERSE EFFECTS; DRUG LABELING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; STANDARDS;

DRUG LABELING; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; IMMUNIZATION; PREGNANCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84948098424     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.05.107     Document Type: Article

References (9)

1. Federal Food, Drug, and Cosmetic Act, 21 USC §352.
2. Code of Federal Regulations, 21 C.F.R. Part 201 (2015).
3. Fed Regist. 2006 January 24; 71:3921-3997.
4. Fed Regist. 1979 June 26;44:3743444 FR 37434; 6/26/1979.
5. Fed Regist. 2014 December 4;79:72064-72103.
6. Prevention and Control of seasonal influenza with vaccines. MMWR. (RR-07), s.l.: MMWR Recomm Rep, September 2013, vol. 62, pp. 1-43.
7. Vaccines against influenza WHO position paper - November 2012. WHO. 2012, Weekly Epidemiol Rec, vol. 87, pp. 461-476.
8. Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnanct women - Advisory Committee on Immunization Practices. MMWR. 7, Feb 22, 2013, MMWR Morb Mortal Wkly Rep, vol. 62, pp. 131-5.
9. Fed Regist. 2014 December 4; 72104-72105.