Regulatory News

News for regulatory professionals, covering the latest from regulators, new and proposed legislation, research and studies, regulatory trends affecting the healthcare product industries, international standards and more.

Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking

The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, Oceania, TGA Tags: CE Marking, Tony Abbott
CDSCO Forms Task Force Focused on User-Friendly Reforms

India’s Central Drugs Standard Control Organization (CDSCO) has announced the formation of a new task force to undertake a comprehensive review of the existing processes, procedures, forms and licenses used by the agency with the purpose of making them simpler and more user friendly.

Categories: Biologics and biotechnology, Drugs, News, India, CDSCO Tags:
FDA Advisory Committee Calendar

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Postmarket surveillance, News, US, CBER, CDER Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees
Federal Audit Finds FDA Website, Internal Network Vulnerable to Hackers

A government audit of the US Food and Drug Administration (FDA), ordered last year after one of the agency's databases was compromised, has found the agency is vulnerable to hacking attempts which could lead to the loss of sensitive information.

Categories: News, US, FDA Tags: Hacking, FDA Hacked, Report, OIG, DHHS,
Headache Helper: FDA Outlines New Recommendations for Approving Migraine Therapies

The US Food and Drug Administration (FDA) is calling for a new approach in the way companies develop drugs intended to treat active migraines, a type of severe, long-lasting headache often characterized by a patient's sensitivity to light and sound.

Categories: Drugs, Clinical, News, US, CDER Tags: Migraine, Guidance, Draft Guidance
Regulatory Recon: US Government Investigating Cybersecurity of Medical Devices (22 October 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
When the FDA Inspector Comes, What are the Chances of a Really Bad Outcome?

It’s generally nerve-wracking when the FDA shows up at your door for an inspection. Knowing what to expect can help.

Categories: Audit, Regulatory intelligence, News, US, FDA Tags: OIA, VAI, NAI, Inspections, FDA Inspections, FDA Inspection Data, RIQ, Regulatory Intelligence Quotient
FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections

The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of inspections.

Categories: Biologics and biotechnology, Drugs, Audit, Ethics, News, US, CDER Tags: Guidance, Final Guidance, Inspection, Delayed Inspection, Denied Inspection, Adulterated, Import Alert, FDA Photography
Regulatory Recon: FDA, EMA Look to New Frameworks to Combat Ebola (17-21 October 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Announces Major Agency Reorganization, With Focus on Drug Quality

The US Food and Drug Administration (FDA) is finally preparing to launch the Office of Pharmaceutical Quality (OPQ), a new effort to focus on the quality of drug products.

Categories: Drugs, Manufacturing, Quality, News, US, CDER Tags: OPQ, Office of Pharmaceutical Quality, Super Office, FDA Reorganization, Drug Quality, Pharmaceutical Quality
Regulatory Recon: FDA Approves Two Drugs for Rare, Fatal Lung Disease (16 October 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Expanding Device Program Intended to Make 510(k) Submissions Easier

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is once again expanding an electronic submission pilot program meant to make it substantially easier for companies to create and submit a 510(k) premarket submission to the agency.

Categories: Medical Devices, Submission and registration, News, US, CDRH Tags: 510(k), Premarket Submission, Premarket Notification, eSubmissions Pilot
As US Falters in Fight Against Antibiotics Over-Prescribing, EU Makes Progress

The European Union seems to be making substantial strides in something the US thus far has been unable to do: reducing the use of antibiotics in food-producing animals.

Categories: Drugs, Veterinary products, News, US, Europe, FDA, EMA, EC Tags: Antimicrobials, Antibiotics, Antibiotic, Antibiotic Prescribing
FDA Wants to Study if Drug Color, Shape and Size Affect Patient Adherence

US drug regulators have long known that the physical attributes of a drug product can affect its safety and efficacy. Now the US Food and Drug Administration (FDA) wants to know exactly how a change in a drug's appearance affects patient adherence.

Categories: Prescription drugs, Generic drugs, News, US, CDER Tags: Pill, Shape, Tablet, Color, Size, Survey, Patient Adherence
Regulatory Recon: Australia Announces Major Change in Device Regulation Policies (15 October 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Recall or Removal? New FDA Device Guidance Clarifies Murky Definitions

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has finally put the finishing touches on a controversial guidance regarding how to distinguish the recall of a device from a market withdrawal.

Categories: Medical Devices, Distribution, Postmarket surveillance, News, US, CDRH Tags: Recall, 21 CFR 806, Guidance, Final Guidance, Correction, Removal, Enhancement
Chinese Company Used Suppliers Linked to Contaminated Heparin Scandal, FDA Claims

A Chinese-based manufacturer of heparin products has been sent a Warning Letter by the US Food and Drug Administration (FDA) after regulators accused the company of preventing FDA inspectors from accessing the facility earlier this year, and possibly manufacturing contaminated products.

Categories: Biologics and biotechnology, Compliance, Ethics, Manufacturing, Quality, News, US, China, FDA Tags: Heparin, Import Alert, Warning Letter
Regulatory Recon: FDA's Woodcock Explains Agency's Biosimilars Stance (14 October 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
To Meet Ebola Threat, Father of FDA's Priority Review Voucher System Calls for Reforms

One of the fathers of a little-known and lesser-used regulatory pathway meant to incentivize the approval of new drugs for so-called "neglected tropical diseases" says Congress needs to include Ebola on the short list of diseases eligible for incentives.

Categories: Drugs, Orphan products, Submission and registration, News, US, CDER Tags: Priority Review, Voucher, Tropical Disease Priority Review Voucher, FDAAA, Tropical Disease, Ebola
As Frozen Poop Pills Shown to be Effective in Study, FDA Policy in the Spotlight

The US Food and Drug Administration (FDA) has a frozen poop problem, and it's getting messier with time.

Categories: Human cell and tissue, Clinical, Ethics, Manufacturing, News, US, CBER Tags: FMT, C. diff, C. difficile, fecal microbiota transplantation, guidance
FDA Changes Policy Hours Before Approvals, Giving Companies Gift Potentially Worth Billions

On Friday, two companies were the lucky recipients of gifts never before given by the US Food and Drug Administration (FDA)—gifts potentially worth millions, if not billions of dollars in value.

Categories: Drugs, Submission and registration, News, US, CDER Tags: NCE, Exclusivity, Approval, Five-Year Exclusivity, Harvoni, Akynzeo, NCE Exclusivity
Regulatory Recon: Software Issue May Mean Incorrect Data Used to Support Generic Drug Approvals (13 October 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Anvisa Updates BA, BE Test Best Practices Certification

Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies. 

Categories: Generic drugs, Compliance, News, Latin America and Caribbean, Anvisa Tags: BA, BE, Bioavailability, Bioequivalence, Certification of Good Practice
European Commission Issues Final Opinion on Metal-on-Metal Hip Implants

The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) issued on 9 October 2014 its final opinion regarding the safety of Metal-on-Metal (MoM) joint replacements, and hip implants in particular.

Categories: Medical Devices, Postmarket surveillance, News, Europe, EC Tags: MoM, Metal-on-metal, hip implants, joint replacement, SCENIHR
With $5 Million Grant, FDA Wants to Change how the US Responds to Future Public Health Emergencies

A new $4.9 million contract awarded by the US Food and Drug Administration (FDA) seeks to improve how the agency deploys medical countermeasures during public health crises like Ebola.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, News, US, FDA Tags: Ebola, Public Health Emergency, MCMi, Contract, Influenza
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