Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and Drug Administration-Partnering With Industry; Public Conference, 13766 [2010-6265]

Download as PDF 13766 Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Notices Ave., Bldg. 22, rm. 5122, Silver Spring, MD 20993–0002, 301–796–0910. SUPPLEMENTARY INFORMATION: jlentini on DSKJ8SOYB1PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Irritable Bowel Syndrome—Clinical Evaluation of Products for Treatment.’’ This guidance is intended to assist the pharmaceutical industry and other investigators who are conducting new product development for the treatment of IBS–D and IBS–C. A content-valid PRO instrument that measures the clinically important signs and symptoms associated with each IBS subtype is the ideal primary efficacy assessment tool in clinical trials used to support labeling claims. However, at this time, an adequate instrument is not available. We recognize that it will take some time to develop adequate instruments and that in the meantime there is a great need to develop effective therapies for patients with IBS. Therefore, until the appropriate PRO instruments have been developed, this guidance recommends interim strategies for IBS clinical trial design and endpoints, and discusses the future development of PRO instruments for use in IBS clinical trials. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on clinical evaluation of products for the treatment of irritable bowel syndrome. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ VerDate Nov<24>2008 16:31 Mar 22, 2010 Jkt 220001 Guidances/default.htm or https:// www.regulations.gov. Dated: March 17, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–6310 Filed 3–22–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and Drug Administration—Partnering With Industry; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a joint conference with the University of Rhode Island (URI) College of Pharmacy entitled ‘‘FDA and PAT for Pharma Manufacturing: FDA—Partnering with Industry.’’ This 2-day public conference is cosponsored by FDA and the URI College of Pharmacy. This public conference is intended to disseminate current and accurate information on process analytical technology (PAT) to the pharmaceutical industry and create a venue for dialogue between PAT users and FDA. The public conference will feature FDA’s perspective on where PAT will be applicable in the manufacturing process and FDA’s current thinking on how PAT will be reviewed in new and abbreviated new drug applications, amendments, or supplements to an application. Date and time: The public conference will be held on May 11 and 12, 2010, from 8 a.m. to 5 p.m. Location: The public conference will be held at the Hyatt Regency Bethesda, One Bethesda Metro, Bethesda, MD 20814, 301–657–1234. Contact Persons: For information regarding the conference and registration: Christi Counts, Pharma Conference Inc., P.O. Box 291386, Kerrville, TX, 78029–1386, 830–896–0027, FAX: 830–896–0029, https://www.pharmaconference.com. For information regarding this notice: Chris Watts, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4142, Silver Spring, MD 20993–0002, 301–796–1625. Registration: There is a registration fee. The registration fee includes PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 conference materials, continental breakfast, breaks, and lunches. For payment received by April 15, 2010, the fee is $1,795. For payment received after April 15, 2010, the fee is $1,995. The fee for government employees is $750. The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks. No checks will be accepted on site. Early registration is recommended because seating is limited. There will be no onsite registration. To register for the public conference online, please visit https://www.pharmaconference.com/ upcoming2010/beth_10.htm. To register by mail, please send your name, title, firm name, address, telephone and fax numbers, e-mail, and credit card information or a company check for the fee to Pharma Conference Inc., P.O. Box 291386, Kerrville, TX, 78029–1386. To register by overnight mail, the address is Pharma Conference Inc., 819 Water St., suite 350, Kerrville, TX, 78028. If you need special accommodations due to a disability, please notify Pharma Conference Inc., once you receive your registration confirmation so these needs can be passed on to the conference venue. Dated: March 17, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–6265 Filed 3–22–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0201] (formerly Docket No. 2007D–0118) Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.’’ This guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and in complying with the requirements in the final rule on the content and format of labeling for E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 75, Number 55 (Tuesday, March 23, 2010)]
[Notices]
[Page 13766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6265]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Food and Drug Administration and Process Analytical Technology 
for Pharma Manufacturing: Food and Drug Administration--Partnering With 
Industry; Public Conference

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public conference.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a joint 
conference with the University of Rhode Island (URI) College of 
Pharmacy entitled ``FDA and PAT for Pharma Manufacturing: FDA--
Partnering with Industry.'' This 2-day public conference is cosponsored 
by FDA and the URI College of Pharmacy. This public conference is 
intended to disseminate current and accurate information on process 
analytical technology (PAT) to the pharmaceutical industry and create a 
venue for dialogue between PAT users and FDA. The public conference 
will feature FDA's perspective on where PAT will be applicable in the 
manufacturing process and FDA's current thinking on how PAT will be 
reviewed in new and abbreviated new drug applications, amendments, or 
supplements to an application.
    Date and time: The public conference will be held on May 11 and 12, 
2010, from 8 a.m. to 5 p.m.
    Location: The public conference will be held at the Hyatt Regency 
Bethesda, One Bethesda Metro, Bethesda, MD 20814, 301-657-1234.
    Contact Persons:
    For information regarding the conference and registration: Christi 
Counts, Pharma Conference Inc., P.O. Box 291386, Kerrville, TX, 78029-
1386, 830-896-0027, FAX: 830-896-0029, https://www.pharmaconference.com.
    For information regarding this notice: Chris Watts, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 4142, Silver Spring, MD 20993-0002, 301-
796-1625.
    Registration: There is a registration fee. The registration fee 
includes conference materials, continental breakfast, breaks, and 
lunches. For payment received by April 15, 2010, the fee is $1,795. For 
payment received after April 15, 2010, the fee is $1,995. The fee for 
government employees is $750. The following forms of payment will be 
accepted: American Express, Visa, Mastercard, and company checks. No 
checks will be accepted on site. Early registration is recommended 
because seating is limited. There will be no onsite registration. To 
register for the public conference online, please visit https://www.pharmaconference.com/upcoming2010/beth_10.htm. To register by 
mail, please send your name, title, firm name, address, telephone and 
fax numbers, e-mail, and credit card information or a company check for 
the fee to Pharma Conference Inc., P.O. Box 291386, Kerrville, TX, 
78029-1386. To register by overnight mail, the address is Pharma 
Conference Inc., 819 Water St., suite 350, Kerrville, TX, 78028.
    If you need special accommodations due to a disability, please 
notify Pharma Conference Inc., once you receive your registration 
confirmation so these needs can be passed on to the conference venue.

    Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6265 Filed 3-22-10; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.