DHHS-FDA Notice of Opportunity for Hearing; Frederick Coulston, Ph.D.

… and telephone communications with CF, including two warning letters and a consent agreement, from July 1999 to the … studies; and, c) Lesser regulatory actions, including two warning letters and a consent agreement have not resulted in …

FDAAA Implementation – Highlights One Year After Enactment

… 8 Written Requests 5 Amended Written Requests 2 Inadequate Letters Internal Processes established for expansion of … all conventional antipsychotic medications to add a Boxed Warning and other warningsto their prescribing information … antimicrobial drugs for systemic use to add a Boxed Warning to their prescribing information indicating an …

09-10-0010 Bioresearch Monitoring Information System, HHS/FDA

… information and/or correspondence, including untitled letters, Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letters, Notice of Opportunity for Hearing (NOOH) letters, and warning letters issued to clinical investigators, and summary …

Electronic Reading Room

… For You FDA Debarment List (Drug Product Applications) Warning Letters   … Office of Regulatory Affairs … Links to each …

Minutes of Institutional Review Board (IRB) Meetings

… III. DISCUSSION IRBs have been cited in OHRP Determination Letters 1 and FDA Warning Letters 2 for failing to prepare and maintain … website and can be viewed by the date issued. 2. FDA Warning Letters are posted on the FDA.gov website and can be …

DHHS-FDA Notice of Opportunity for Hearing; Peter K. Law, Ph.D.

… investigator to receive investigational new drugs. By letters dated June 30, 2000, and August 17, 2001, the Center … of Title 21 of the Code of Federal Regulations (CFR). The letters also gave you the option of entering into a consent … against you. You chose to respond in writing, in letters dated September 6, 2000, December 20, 2000, and …

Davidson, Jeffrey N., D.V.M. Presiding Officers Report

… practices. Only in 1995, however, did the Center issue a warning letter to Dr. Davidson, proposing to disqualify him … On November 7,1997, more than two years after sending the warning letter, CVM initiated this proceeding by sending Dr. … were conducted in the late 1980's, giving rise to warning letters in 1995. CVM issued an NOOH to Dr. Davidson in 1997 …

Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)

… the standardized language provided in the boilerplate letters 3 or may include other labeling limitations specific …

DHHS-FDA Regulatory Hearing on the Proposal to Disqualify Charles M. Singleton, M.D. from Receiving Investigational New Drugs

… study in February and March 1996, FDA sent Dr. Singleton a Warning Letter dated July 2, 1996, regarding certain violations the investigators observed. The Warning Letter was sent by certified mail to Dr. Singleton at … did not specifically respond to this allegation in his two letters to FDA. Putting aside the question of whether 21 …

Guidance for Industry: Food Security Preventive Measures Guidance for Food Producers, Processors, and Transporters

… federal government's focal point for threat assessment, warning, investigation, and response for threats or attacks … the NIPC identifies credible threats and crafts specific warning messages to the food industry. Further information is … that are contained in purchase and shipping contracts or letters of credit, or using a vendor approval program) …

Small Entity Compliance Guide: Juice HACCP

… government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to: … be heat treated to destroy pathogens. 55. May I use the warning label statement on my products in lieu of … a HACCP system? Generally speaking, use of the juice label warning statement is not an alternative to compliance with …

Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)

… necessary for any assembly/disassembly. Also, include a warning that the device should be thoroughly cleaned and … , pp.422-424. Treatment of dysfunctional uterine bleeding (letters) (1995) British Medical Journal, 310 (9982), …

Guidance for Industry: Questions and Answers on Juice HACCP Regulation

… government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to: … be heat treated to destroy pathogens. 63. May I use the warning label statement on my products in lieu of … a HACCP system? Generally speaking, use of the juice label warning statement is not an alternative to compliance with …

CPG Sec 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

… FDA may elect to refuse prior notices or send Compliance letters to give the responsible parties warning prior to pursuing other regulatory actions, e.g., …

Guidance on the Content and Organization of a Premarket Notification for a Medical Laser

… should be noted. Provide a complete name and identifying letters and numbers for the standard, including the year of … steps that should be taken should they occur. Include any warning when there is reasonable evidence of an association …

Guidance Document For Nonprescription Sunglasses - Guidance for Industry

… labeling and advertising from several manufacturers. Warning letters have been issued by FDA to manufacturers advising …

Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer]

… onset of haze beyond 6 months with loss of 2 lines (10 letters) or more BSCVA J. Decrease in BSCVA of >10 letters not due to irregular astigmatism as shown by hard … away from other electrical medical devices and provide a warning in all labeling that the effects of the laser on …

Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers

… Control Devices Branch before responding to deficiency letters to clarify or discuss the deficiencies. Within 30 … following information: 1) potential safety hazards, e.g., "Warning, Toxic Strips. Contain the following chemicals:…" and …

Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition

… labeling regulation in 21 CFR 101.17(g) that requires a warning statement on packaged fruit and vegetable juice … HACCP regulation such as effective dates, use of the label warning statement, and training. Additional information on … individuals. 6 In the January 22, and January 25, 2002 letters, FDA described high degree Brix juice concentrate as …