Regulatory Doctor

19
Mar

US FDA and Health Canada Audit Program Status for ISO 13485

The United States Food and Drug Administration (FDA) The Center for Devices and Radiological Health (CDRH) Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program The FDA/CDRH is terminating Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program. FDA will no longer accept ISO 13485:2003 voluntary audit reports with an audit end date of April 1, 2016

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15
Mar

Definitions for Medical Device Safety and Effectiveness

Safety, Effectiveness and Valid Scientific Evidence for Medical Devices Pursuant to the FDA regulations under 21 CFR Part 860, the following terms are defined. Safety There is reasonable assurance that a device is safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and

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2
Feb

US Federal Healthcare Laws for Fraud and Abuse

The United States Statutes and Regulations for Healthcare Fraud and Abuse The Anti-Kickback Statute 42 U.S.C. § 1320a–7b(b) Safe Harbor Regulations: 42 C.F.R. § 1001.952 Listen to the US DHHS OIG’s Presentation about the Anti-Kickback Statute [youtube_advanced url=”https://www.youtube.com/watch?v=a4KhqqeAaUg” controls=”no” loop=”yes” rel=”no” modestbranding=”yes”] The False Claims Act (FCA) 31 U.S.C. §§ 3729-3733 Listen to the US DHHS OIG’s Presentation about the

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31
Jan

FDA Drug Information on Progesterone

Regulatory Status Information for Drug Progesterone FDA Approved Drugs (Drug Name and Active Ingredients) AMEN: MEDROXYPROGESTERONE ACETATE by AMARIN PHARMS CRINONE: PROGESTERONE – Vaginal Gel by ACTAVIS LABS UT INC CURRETAB: MEDROXYPROGESTERONE ACETATE – Oral Tablet by SOLVAY (Discontinued) CYCRIN: MEDROXYPROGESTERONE ACETATE – Oral Tablet by ESI (Discontinued) DELALUTIN: HYDROXYPROGESTERONE CAPROATE – Injectable/Injection by BRISTOL MYERS SQUIBB (Discontinued) DEPO-PROVERA: MEDROXYPROGESTERONE ACETATE – Injectable/Injection (150

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14
Jan

FDA Needs to Improve Oversight of Postapproval Data

United States Government Accountability Office (GAO) The following report is published dated December 15, 2015 and released to the public on January 14, 2016 Report to the Ranking Member, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations, House of Representatives DRUG SAFETY FDA Expedites Many Applications, But Data for Postapproval Oversight Need From October

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30
Dec

Proposed Final Documents for Medical Device Harmonization in Asia

Asian Harmonization Working Party (AHWP) AHWP is established as a non-profit organization. Its goals are to study and recommend ways to harmonize medical device regulations in the Asian and other regions. AHWP recently issued PROPOSED Final Documents for medical device harmonization in Asian countries. AHWP’s PROPOSED Final Documents Common Submission Dossier Template (CSDT) [download id=”22589″] 2015 CSDT is also available here.

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28
Dec

FCC Provides Ten Cybersecurity Tips for Small Businesses

Federal Communications Commission (FCC) A recent study found that having a broadband connection makes a $200,000 a year difference in median annual revenues for businesses, by reaching new markets and increasing productivity. The FCC released a Cybersecurity Tip Sheet, which outlines the top ten ways entrepreneurs can protect their companies – and customers – from cyberattack. Cybersecurity Roundtable: Protecting Small Businesses [youtube_advanced

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18
Dec

First Insulin Glargine Similar to Lantus Approved Under 505b2 Pathway

The U.S. Food and Drug Administration (FDA) Basaglar (insulin glargine injection) A long-acting human insulin analog The FDA approved Basaglar to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2

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18
Dec

FDA Proposes Restricted Use and Special Controls of Sunlamp Products

Food and Drug Administration (FDA) FDA Proposes Two Rules: 1). to Restrict Sale, Distribution, and Use of Sunlamp Products including 2). Amendment to Performance Standard.  On December 18, 2015, the U.S. FDA announced important proposed steps ‎to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of

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12
Dec

OSHA Fines to Significantly Rise for The First Time Since 1990

Occupational Safety and Health Administration (OSHA) With the Occupational Safety and Health Act of 1970, Congress created the OSHA to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. Bipartisan Budget Act of 2015 11/02/2015 Became Public Law No: 114-74 According to the Bipartisan Budget Act, signed

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