federal_register: 2012-29461
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012-29461 | Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products." This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular, the guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products, including prescription and nonprescription products. | 2012-12-06 | 2012 | 12 | https://www.federalregister.gov/documents/2012/12/06/2012-29461/guidance-for-industry-on-limiting-the-use-of-certain-phthalates-as-excipients-in-center-for-drug | https://www.govinfo.gov/content/pkg/FR-2012-12-06/pdf/2012-29461.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products." This guidance provides the pharmaceutical industry with the... |