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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
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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
By - Roger Cowan
On Demand Access Anytime
By - Roger Cowan
On Demand Access Anytime
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HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
By - Roger Cowan
On Demand Access Anytime
By - Roger Cowan
On Demand Access Anytime
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Extractables and Leachables in Early Phase Development
By - Wayland Rushing
On Demand Access Anytime
By - Wayland Rushing
On Demand Access Anytime
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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
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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
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Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochin ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is revising its requirements for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carminecontaining food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This action also responds to a citizen petition submitted by the Center for Science in the Public Interest (CSPI)
Effective Date: This rule is effective January 5, 2011
ICH Guidance Annex 3: Test for Particulate Contamination: Subvisible Particles
- 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 3: Test for Particulate Contamination: Subvisible Particles 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 Test for Particulate Contamination: Subvisible Particles 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 Q4B Evaluation and Recommendation of Pha ....
- 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 3: Test for Particulate Contamination: Subvisible Particles 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 Test for Particulate Contamination: Subvisible Particles 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; Phenylbutazone Tablets and Boluses
- 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 First Priority, Inc. The supplemental application provides for revising the description of a 1-gram oral dosage form of phenylbutazone from tablet to bolus
Effective Date: This rule is effective july 12, 2009
Institutional Review Boards;Registration Requirements
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA, we) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The registration information includes contact information (such as addresses and telephone numbers), the number of active protocols involving FDAregulated products reviewed during the preceding 12 months, and a description of the types of FDA-regulated products involved in the protocols reviewed. The IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to IRBs
Effective Date:This rule is effective july 14, 2009
Requirements for Submission of Bioequivalence Data
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because we now believe that data from additional BE studies may be important in our determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD), and are relevant to our evaluation of ANDAs in general. In addition, such data will increase our understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance
Effective Date: Effective Date:This rule is effective july 15, 2009
Final Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administra ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA or agency) is announcing the availability of a guidance for industry entitled ‘‘Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007’’ dated January 2009. The guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency’s current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications as described in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Repo ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report to a central office in the agency. The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Repo ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report to a central office in the agency. The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment
Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over- ....
- Industry: Drugs and Chemicals (Pharma)
We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-thecounter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form in water, are generally recognized as safe and effective (GRASE) and not misbranded as astringent drug products. The amendment also describes how manufacturers should relabel these products to comply with the FM. We are issuing this amendment in response to a citizen petition (CP) that we received from a manufacturer of OTC astringent drug products. This final rule is part of our ongoing review of OTC drug products
Effective Date:This rule is effective March 6,2009
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 update agency contacts for patent information and patent notifications and to correct an inaccurate cross-reference. This action is being taken to ensure accuracy and clarity in the agency’s regulations.
Effective Date:This rule is effective March 6, 2009
New Animal Drugs; Change of Sponsor; Methoxyflurane
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Schering- Plough Animal Health, Inc., to Medical Developments International, Ltd
New Animal Drugs; Change of Sponsor; Methoxyflurane
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Schering- Plough Animal Health, Inc., to Medical Developments International, Ltd
Effective Date:This rule is effective March 6,2009
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidanc ....
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA.’’ This guidance document describes a means by which an enterovirus nucleic acid assay may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule codifying the classification of the enterovirus nucleic acid assays into class II (special controls). This guidance document is immediately in effect as the special control for an enterovirus nucleic acid assay, but it remains subject to comment in accordance with the agency’s good guidance practices (GGPs)
ICH Guidance Annex 2: Test for Extractable Volume of Parenteral Preparations
- 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 2: Test for Extractable Volume of Parenteral Preparations 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 Test for Extractable Volume of Parenteral Preparations 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
New Animal Drugs; Change of Sponsor; Methoxyflurane
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Schering- Plough Animal Health, Inc., to Medical Developments International, Ltd
Oral Dosage Form New Animal Drugs; Amprolium
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for the use of generic amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis
Effective Date:This rule is effective March, 11 2009
Other Dosage Form New Animal Drugs; Sevoflurane
- 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 Abbott Laboratories, Inc. The supplemental NADA provides for a revised induction dose of sevoflurane inhalant anesthetic in dogs
Effective Date: This rule is effective march 11,2009
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
- Industry: Drugs and Chemicals (Pharma)
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in dairy cattle for control of pyrexia associated with acute bovine mastitis
Effective Date: This rule is effective Feb 12,2009
Implantation or Injectable Dosage Form New Animal Drugs; Tylosin
- 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 Elanco Animal Health. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for tylosin injectable solution
Effective Date: This rule is effective March 19,2009
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