Your Shopping Cart
Compliance Regulations and Guidance Affecting your Industry
Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.Categories
Compliance Trainings
![](/images/products/medium/703727.jpg)
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
By - Roger Cowan
On Demand Access Anytime
By - Roger Cowan
On Demand Access Anytime
![](/images/products/medium/703831.jpg)
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
By - Roger Cowan
On Demand Access Anytime
By - Roger Cowan
On Demand Access Anytime
![](/images/products/medium/704517.jpg)
Extractables and Leachables in Early Phase Development
By - Wayland Rushing
On Demand Access Anytime
By - Wayland Rushing
On Demand Access Anytime
![](/images/products/medium/705019.jpg)
Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
By - Gwen Wise Blackman
On Demand Access Anytime
By - Gwen Wise Blackman
On Demand Access Anytime
![](/images/products/medium/705148.jpg)
![](/images/products/medium/705325.jpg)
Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>
By - Gregory Martin
On Demand Access Anytime
By - Gregory Martin
On Demand Access Anytime
![Please Wait.... Loading....](https://www.complianceonline.com/images/newUI/images/ajax-loader.gif)
Change of Addresses and Names;Technical Amendment
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending its regulations to reflect a change of address for the Center for Drug Evaluation and Research’s (CDER’s) Central Document Room in Beltsville, MD; the relocation of certain CDER offices to the White Oak campus in Silver Spring, MD; and changes of the names of certain CDER organizational units. This action is editorial in nature and is intended to ensure the accuracy and clarity of the agency’s regulations
Effective Date: This rule is effective March 26, 2009
ICH Guidance - Annex 4B: Microbiological Examination of Nonsterile Products: Tests for Specifie ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
International Conference on Harmonisation; Guidance on Q10 Pharmaceutical Quality System; Avail ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Q10 Pharmaceutical Quality System.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on ‘‘Q8 Pharmaceutical Development’’ and ‘‘Q9 Quality Risk Management
ICH Guidance - Annex 4A: Microbiological Examination of Nonsterile Products: Microbial Enumerat ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
ICH Guidance - Annex 4C: Microbiological Examination of Nonsterile Products
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4C: Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Oral Dosage Form New Animal Drugs;Fenbendazole Suspension
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for a revised human food safety warning for use of fenbendazole suspension in horses
Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document.’’ Since FDA began accepting new drug application (NDA) and biologics license application (BLA) submissions in the common technical document (CTD) format, there has been confusion regarding where within the CTD to include an integrated summary of effectiveness (ISE) and integrated summary of safety (ISS), both of which are required components of an NDA submission and recommended components of a BLA submission. This guidance informs applicants where to place the ISE and ISS in the CTD, addresses specific FDA requirements not discussed in the ICH guidance for industry ‘‘M4E: The CTD—Efficacy,’’ and is intended to improve application quality and consistency. This guidance finalizes the draft guidance of the same title published in the Federal Register of July 3, 2007 (72 FR 36471))
Intramammary Dosage Forms; Change of Sponsor
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Merial Ltd. to Cross Vetpharm Group Ltd
Effective Date: This rule is effective April 27,2009
Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for O ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is issuing this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal antiinflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA).
Effective Date: This final rule is effective April 29, 2010
Ophthalmic and Topical Dosage Form New Animal Drugs; Selamectin
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA revises the minimum age of treatment from 6 weeks to 8 weeks for kittens treated with a topical selamectin solution
Effective Date:This rule is effective April 30,2009
New Animal Drugs; Change of Sponsor’s Name
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from IVX Animal Health, Inc., to Teva Animal Health, Inc
Effective Date: This rule is effective May 5, 2009
New Animal Drugs; Change of Sponsor’s Name
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from IVX Animal Health, Inc., to Teva Animal Health, Inc.
New Animal Drugs; Trilostane
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by Dechra, Ltd. The NADA provides for the veterinary prescription use of trilostane capsules in dogs for treatment of pituitary-dependent hyperadrenocorticism and for treatment of hyperadrenocorticism due to adrenocortical tumor
Effective Date:This rule is effective May 11,2009
New Animal Drugs; Carprofen
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the veterinary prescription use of carprofen caplets in dogs
Effective Date: This rule is effective May 11,2009
Compliance Guidance for Small Business Entities on Labeling Overthe- Counter Human Drug Product ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled ‘‘Labeling OTC Human Drug Products; Small Entity Compliance Guide.’’ FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand and comply with the agency’s over-the-counter (OTC) labeling requirements and to prepare new labeling. This compliance guidance finalizes the draft compliance guidance published on December 9, 2004
New Drug Applications and Abbreviated New Drug Applications;Technical Amendment
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to correct the address for the Orange Book Staff in the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency’s regulations
Effective Date: This rule is effective July 24, 2009
Guidance for Industry: Nucleic Acid Testing To Reduce the Possible Risk of Human Parvovirus B19 ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products,’’ dated July 2009. The guidance document provides to manufacturers of plasma-derived products recommendations for performing parvovirus B19 NAT as an in-process test for Source Plasma and recovered plasma to identify and help to prevent the use of plasma units containing high levels of parvovirus B19. The guidance also recommends how to report to FDA implementation of parvovirus B19 NAT. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2008
Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Availabil ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Drug-Induced Liver Injury: Premarketing Clinical Evaluation.’’ This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI) during the conduct of premarketing trials. This guidance defines severe DILI as injury that is fatal or requires liver transplantation
New Animal Drugs; Nitrofurazone Ointment
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for use of nitrofurazone ointment on horses for prevention or treatment of superficial bacterial infections
Effective Date: This rule is effective August 3, 2009
Charging for Investigational Drugs Under an Investigational New Drug Application
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency’s final rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted previously
Effective Date:This rule is effective October 13,2009
You Recently Viewed