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/700851.jpg)
How FDA trains its investigators to review CAPA and what should you do to prepare
By - Jeff Kasoff
On Demand Access Anytime
By - Jeff Kasoff
On Demand Access Anytime
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
By - David Nettleton
Live September 10, 2024
By - David Nettleton
Live September 10, 2024
![](/images/products/medium/701585.jpg)
Water System Investigation "How-To's" and Example Case Studies
By - T.C Soli
On Demand Access Anytime
By - T.C Soli
On Demand Access Anytime
![](/images/products/medium/701766.jpg)
Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
By - Jim Polarine
On Demand Access Anytime
By - Jim Polarine
On Demand Access Anytime
![](/images/products/medium/703875.jpg)
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
By - Charity Ogunsanya
On Demand Access Anytime
By - Charity Ogunsanya
On Demand Access Anytime
![](/images/products/medium/704531.jpg)
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
By - Joy McElroy
On Demand Access Anytime
By - Joy McElroy
On Demand Access Anytime
![Please Wait.... Loading....](https://www.complianceonline.com/images/newUI/images/ajax-loader.gif)
21 CFR Parts 556 and 558 Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
DATES: This rule is effective May 17, 2010.
Agency Information Collection Activities; Submission for Office of Management and Budget Review ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June 7, 2010.
Guidance for Industry - Planning for the Effects of High Absenteeism to Ensure Availability of ....
- Industry: All FDA Regulated Industry
This guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities.
Guidance for Industry and FDA Staff - Enforcement Policy Concerning Certain Regulations Restric ....
- Industry: All FDA Regulated Industry
This guidance is intended to provide information related to certain provisions of the regulations restricting the sale and distribution of cigarettes and smokeless tobacco. See 75 Federal Register 13225 (March 19, 2010). These regulations are effective June 22, 2010.1 More specifically, this guidance provides clarifying information related to FDA’s enforcement policy concerning 21 CFR sections 1140.16(a) and 1140.32(a) of the final rule.
Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling f ....
- Industry: All FDA Regulated Industry
This guidance provides FDA’s current thinking on non-clinical engineering tests that are submitted in investigational device exemption applications (IDEs) and premarket approval applications (PMAs) to support the safety and effectiveness of intravascular stents and their associated delivery systems. This guidance also provides recommendations for labeling for these devices.
Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ....
- Industry: All FDA Regulated Industry
The guidance document describes the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.
New Animal Drugs; Change of Sponsor's Name
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor’s mailing address will be changed.
Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Flunisolide, etc.)
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA’s regulation on the use of ozonedepleting substances (ODSs) in selfpressurized containers to remove the essential-use designations for flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil as products that do not release ODSs, and therefore they will no longer be essential uses of ODSs as of the effective dates of this rule. MDIs for these active moieties containing an ODS may not be marketed after the relevant effective date.
DATES: Removal of § 2.125(e)(2)(iii) and § 2.125(e)(4)(vii) is effective June 14, 2010. Removal of § 2.125(e)(1)(v) and § 2.125(e)(4)(iv) is effective December 31, 2010. Removal of § 2.125(e)(1)(iii) is effective June 30, 2011. Removal of § 2.125(e)(2)(iv) and § 2.125(e)(4)(viii) is effective December 31, 2013.
New Animal Drugs; Change of Sponsor’s Name and Address
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor’s mailing address will be changed.
New Animal Drugs; Change of Sponsor’s Name and Address
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor’s name from Parnell Laboratories (Aust) Pty. Ltd. to Parnell Technologies Pty. Ltd. In addition, the sponsor’s mailing address will be changed.
DATES: This rule is effective April 20, 2010.
Certain Other Dosage Form New Animal Drugs; Detomidine
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Orion Corp. The NADA provides for veterinary prescription use of detomidine hydrochloride oromucosal gel for sedation and restraint of horses.
DATES: This rule is effective April 23, 2010.
Center for Devices and Radiological Health; New Address Information
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is amending procedural regulations that pertain to obtaining, submitting, executing, and filing certain documents to reflect new address information for the Center for Devices and Radiological Health (CDRH). All filings and other documents that are subject to these regulations must be directed to the new addresses. This action is being taken to provide accuracy and clarity to the agency’s regulations.
DATES: This regulation is effective April 22, 2010.
Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Reque ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.’’ This draft guidance describes the user fees associated with 513(g) requests for information.
DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 28, 2010. Submit written or electronic comments on the collection of information June 28, 2010.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of an existing collection of information pertaining to the submission of tobacco health documents under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
DATES: Submit written or electronic comments on the collection of information by June 21, 2010.
Agency Information Collection Activities; Submission for Office and Management and Budget Revie ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June 1, 2010.
Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administratio ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.’’ This draft guidance is not final nor is it in effect at this time. Elsewhere in this issue of the Federal Register, FDA is also publishing a notice of availability for a draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.’’
DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on this draft guidance by July 28, 2010. Submit written or electronic comments on the collection of information by June 28, 2010.
Fonterra (USA) Inc.; Filing of Food Additive Petition
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing that Fonterra (USA) Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of hydrogen peroxide in the manufacture of modified whey by the ultrafiltration method.
Determination of Regulatory Review Period for Purposes of Patent Extension; AFINITOR
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) has determined the regulatory review period for AFINITOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing the issuance of 10 Emergency Use Authorizations (EUAs) (the Authorizations) several of which were amended after initial issuance, for certain in vitro diagnostic devices. FDA also is announcing an amendment to the EUA for the Centers for Disease Control and Prevention (CDC) Swine Influenza Virus Real-time RT-PCR Detection Panel authorized on April 27, 2009. FDA is issuing the Authorizations and amendments thereto under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow. the determination by the Acting Secretary of the U.S. Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A, or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanied by emergency use information subject to the terms of any authorization issued under the Federal Food, Drug, and Cosmetic Act (the act). The Authorizations, which include explanations of the reasons for their issuance or reissuance, are reprinted in this document.
DATES: See the SUPPLEMENTARY INFORMATION section of this document for effective dates of the Authorizations.
Amended Authorizations of Emergency Use of Zanamivir, Oseltamivir Phosphate, and Peramivir; Aut ....
- Industry: All FDA Regulated Industry
The Food and Drug Administration (FDA) is announcing amendments to the two Emergency Use Authorizations (EUAs) (the Authorizations) for certain products from the neuraminidase class of antivirals, zanamivir and oseltamivir phosphate, issued on April 27, 2009, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). On July 14, 2009, in response to a request from CDC, FDA amended and reissued in its entirety the Authorization for certain oseltamivir phosphate products. On October 30, 2009, in response to a request from CDC, among other reasons, FDA amended and reissued in their entirety the Authorization letters for certain zanamivir and oseltamivir phosphate products. Finally, on November 4, 2009, FDA amended and reissued in its entirety the Authorization letter for certain zanamivir inhalation powder. The Authorization letter for certain oseltamivir phosphate products, as amended on October 30, 2009, and the Authorization letter for certain zanamivir inhalation powder, as amended on November 4, 2009, including explanations for their reissuance, are reprinted in this document.
DATES: The amended Authorizations are effective as of October 30, 2009.
You Recently Viewed