-
1
-
-
84898895388
-
Recent changes in pregnancy and lactation labeling: Retirement of risk categories
-
Ramoz LL, Patel-Shori NM. Recent changes in pregnancy and lactation labeling: retirement of risk categories. Pharmacotherapy 2014;34(4):389–395.
-
(2014)
Pharmacotherapy
, vol.34
, Issue.4
, pp. 389-395
-
-
Ramoz, L.L.1
Patel-Shori, N.M.2
-
2
-
-
84922324359
-
Content and format of labeling for human prescription drug and biological products: Requirements for pregnancy and lactation labeling
-
Accessed February 13, 2016
-
Food and Drug Administration. Content and format of labeling for human prescription drug and biological products: requirements for pregnancy and lactation labeling. Fed Regist 2014;79(233): 72064–72103. Available at: www.gpo.gov/fdsys/pkg/FR-2014-12- 04/pdf/2014-28241.pdf. Accessed February 13, 2016.
-
(2014)
Fed Regist
, vol.79
, Issue.233
, pp. 72064-72103
-
-
-
3
-
-
84994364451
-
-
Pregnancy, lactation, and reproductive potential: labeling for human prescription drug and biological products—content and format: guidance for industry. December 2014, Accessed February 27
-
Food and Drug Administration. Pregnancy, lactation, and reproductive potential: labeling for human prescription drug and biological products—content and format: guidance for industry. December 2014. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM425398.pdf. Accessed February 27, 2016.
-
(2016)
-
-
-
4
-
-
84931834058
-
An overview of upcoming changes in pregnancy and lactation labeling information
-
Moseley JF 2nd, Smith LL, Dezan MD. An overview of upcoming changes in pregnancy and lactation labeling information. Pharm Pract (Granada) 2015;13(2):605.
-
(2015)
Pharm Pract (Granada)
, vol.13
, Issue.2
, pp. 605
-
-
Moseley, J.F.1
Smith, L.L.2
Dezan, M.D.3
-
5
-
-
77949881007
-
Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling—proposed rule
-
Accessed February 13, 2016
-
Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling—proposed rule. Fed Regist 2008:73(104):30831–30868. Available at: www.regulations.gov/ contentStreamer?documentId=FDA-2006-N-0515-0001&disposit ion=attachment&contentType=pdf. Accessed February 13, 2016.
-
(2008)
Fed Regist
, vol.73
, Issue.104
, pp. 30831-30868
-
-
-
6
-
-
84994283583
-
-
LLC. Evaluation of how best to communicate to healthcare providers about the risks and benefits of prescription drug use for pregnant and nursing women: a mental models research report. September 2009, Accessed March 19, 2016
-
Decision Partners, LLC. Evaluation of how best to communicate to healthcare providers about the risks and benefits of prescription drug use for pregnant and nursing women: a mental models research report. September 2009. Available at: www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. Accessed March 19, 2016.
-
-
-
-
7
-
-
84994345039
-
-
Agency information collection activities; submission for Office of Management and Budget review; comment request; mental models study of communicating with health care providers about the risks and benefits of prescription drug use for pregnant and nursing women with chronic conditions. August 25, 2008, Accessed March 19
-
Food and Drug Administration. Agency information collection activities; submission for Office of Management and Budget review; comment request; mental models study of communicating with health care providers about the risks and benefits of prescription drug use for pregnant and nursing women with chronic conditions. August 25, 2008. Available at: www.fda.gov/ohrms/dockets/98fr/E8-19653.htm. Accessed March 19, 2016.
-
(2016)
-
-
-
8
-
-
84945125337
-
FDA drug labeling for pregnancy and lactation drug safety monitoring systems
-
Greene MF. FDA drug labeling for pregnancy and lactation drug safety monitoring systems. Semin Perinatol 2015;39(7):520–523.
-
(2015)
Semin Perinatol
, vol.39
, Issue.7
, pp. 520-523
-
-
Greene, M.F.1
-
9
-
-
84948098424
-
The U.S. FDA pregnancy lactation and labeling rule–Implications for maternal immunization
-
Gruber MF. The U.S. FDA pregnancy lactation and labeling rule–Implications for maternal immunization. Vaccine 2015;33(47):6499–6500.
-
(2015)
Vaccine
, vol.33
, Issue.47
, pp. 6499-6500
-
-
Gruber, M.F.1
-
10
-
-
84994260284
-
-
Novel drugs 2015. January 2016, Accessed February 13, 2016
-
Food and Drug Administration. Novel drugs 2015. January 2016. Available at: www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DrugInnovation/UCM485053.pdf. Accessed February 13, 2016.
-
-
-
-
11
-
-
84994364446
-
-
Novel drug approvals for 2016. September 21, Accessed March 23, 2016
-
Food and Drug Administration. Novel drug approvals for 2016. September 21, 2016. Available at: www.fda.gov/Drugs/DevelopmentApproval- Process/DrugInnovation/ucm483775.htm. Accessed March 23, 2016.
-
(2016)
-
-
-
12
-
-
84994364481
-
-
Bagsvaerd, Denmark: Novo Nordisk, Accessed April 5, 2016
-
Tresiba (insulin degludec injection) prescribing information. Bagsvaerd, Denmark: Novo Nordisk; 2015. Available at: www.tresibapro.com/about-Tresiba.html. Accessed April 5, 2016.
-
(2015)
-
-
-
13
-
-
84994260288
-
-
Smyrna, Georgia: UCB, Inc, Accessed April 5, 2016
-
Briviact (brivaracetam) prescribing information. Smyrna, Georgia: UCB, Inc.; 2016. Available at: www.briviact.com/briviact-PI.pdf. Accessed April 5, 2016.
-
(2016)
-
-
-
14
-
-
84994345055
-
-
Pine Brook, New Jersey: Elusys Therapeutics, Inc, Accessed October 4, 2016
-
Anthim (obiltoxaximab) prescribing information. Pine Brook, New Jersey: Elusys Therapeutics, Inc.; 2016. Available at: www.anthim.com/download/pdf/ANTHIM-prescribing-information. pdf. Accessed October 4, 2016.
-
(2016)
-
-
-
15
-
-
84994364465
-
-
Whitehouse Station, New Jersey: Merck, Accessed February 13, 2016
-
Zepatier (elbasvir/grazoprevir) prescribing information. Whitehouse Station, New Jersey: Merck; 2016. Available at: www.merck.com/product/usa/pi_circulars/z/zepatier/ zepatier_pi.pdf. Accessed February 13, 2016.
-
(2016)
-
-
-
16
-
-
84994364473
-
-
Horsham, Pennsylvania: Janssen Biotech, Accessed February 13, 2016
-
Yondelis (trabectedin) prescribing information. Horsham, Pennsylvania: Janssen Biotech; 2015. Available at: www.yondelis. com/prescribing-information.pdf. Accessed February 13, 2016.
-
(2015)
-
-
-
17
-
-
84947558473
-
Impact of the Pregnancy and Lactation Labeling Rule (PLLR) on practicing dermatologists
-
13030/qt46c4m2tw
-
Beroukhim K, Abrouk M, Farahnik B. Impact of the Pregnancy and Lactation Labeling Rule (PLLR) on practicing dermatologists. Dermatol Online J 2015;21(11). pii: 13030/qt46c4m2tw.
-
(2015)
Dermatol Online J
, vol.21
, Issue.11
-
-
Beroukhim, K.1
Abrouk, M.2
Farahnik, B.3
-
18
-
-
84994345058
-
-
FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products. December 3, Accessed February 13, 2016
-
Food and Drug Administration. FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products. December 3, 2014. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm. Accessed February 13, 2016.
-
(2014)
-
-
|