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.

FDA Finalizes Two Medical Device Guidelines

The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform benefit-risk determinations.

Categories: In vitro diagnostics, Medical Devices, Government affairs, Preclinical, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH Tags: FDA guidance, medical device guidance, benefit-risk determinations of devices
FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies.

Categories: Drugs, Medical Devices, Clinical, Due Diligence, Preclinical, News, US, FDA Tags: GLP regulations, nonclinical studies, quality inspections, FDA proposed rules
Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017.

Categories: Medical Devices, Government affairs, Postmarket surveillance, Preclinical, Project management, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH Tags: MDUFA, medical device user fee agreement, AdvaMed, MITA, CLIA, LDTs
Regulatory Recon: FDA Clears Computerized Test for Post-Concussion Cognitive Function; Bioclinica Bought by Private Equity Firm in $1.4B Deal (23 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Asia Regulatory Roundup: CFDA Revises Preclinical Guidance (23 August 2016)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: Drugs, Due Diligence, Preclinical, News, Asia, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, preclinical guidance, CFDA reforms
FDA Clears Test for Measuring Post-Concussion Cognitive Function

The US Food and Drug Administration (FDA) on Monday announced it cleared the first computer-based tests for measuring cognitive function after a suspected concussion in both adults and children.

Categories: Medical Devices, News, FDA Tags: Concussions, ImPACT
Industry, Patient Groups Respond to FDA Guidance on Sharing Patient-Specific Device Data

Several groups representing the medical device industry and patients are calling for more clarity from the US Food and Drug Administration (FDA) on its recent draft guidance on sharing patient-specific device data with patients.

Categories: Medical Devices, News, US, FDA Tags: Patient-Specific Data, Data Sharing
PDUFA Reauthorization: AstraZeneca Offers Detailed Recommendations

Although the performance and procedural goals for the sixth iteration of the Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the user fee program from fiscal years 2018 through 2022.

Categories: Biologics and biotechnology, Combination products, Drugs, Clinical, Government affairs, Manufacturing, Quality, News, US, FDA Tags: AstraZeneca, PDUFA VI, PDUFA reauthorization, Prescription Drug User Fee Act
Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen

Sen. Amy Klobuchar (D-MN) on Saturday called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies.

Categories: Drugs, Medical Devices, Crisis management, Government affairs, Quality, News, US, FDA, FTC, Business and Leadership Tags: EpiPen, Mylan, Andy Slavitt, Bernie Sanders
Regulatory Recon: Pfizer to Buy Cancer Biotech Medivation in $14 Billion Deal (22 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
EMA Releases List of Medical Events for Pharmacovigilance Monitoring

The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events.

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, News, Europe, EMA Tags: Pharmacovigilance, EudraVigilance, Designated Medical Events, Important Medical Events
Chewable Tablets: Companies Seek Clarity on FDA Draft Guidance

Pfizer, AstraZeneca, Bayer, Genentech and Shire, among others, are seeking more clarity from the US Food and Drug Administration (FDA) on draft guidance covering the critical quality attributes drugmakers should consider when developing chewable tablets.

Categories: Drugs, Clinical, Compliance, Manufacturing, Quality, News, US, FDA Tags: chewable tablets, chewable drugs, pharmaceutical comments on FDA guidance, FDA draft guidance
Regulatory Recon: FDA Expands Use of Edwards Sapien Heart Valves; NICE Rejects Bayer's Nexavar for Liver Cancer Over Cost Concerns (19 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.

Categories: Active pharmaceutical ingredients, Drugs, Manufacturing, Product withdrawl and retirement, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, Asia, Oceania, FDA, EMA, MHRA, Health Canada, TGA Tags: GMP inspection, Pfizer, India drug manufacturing, antibiotics manufacturing
FDA Reiterates Concerns on Citizen Petitions Delaying Drug Approvals

Although only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions, the US Food and Drug Administration (FDA) has reiterated its concerns that the petitions do not raise valid scientific issues and are only being used to delay the approval of competing products, according to the Thursday release of the FY 2015 report to Congress on approval delays from citizen petitions.

Categories: Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: citizen petitions, 505(q) petitions, drug approval delays
Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches

Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of US Food and Drug Administration (FDA) draft guidance that aims to improve the way adhesion data is treated for abbreviated new drug application (ANDA) submissions of transdermal delivery systems and topical patches.

Categories: Generic drugs, Clinical, Compliance, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: Perrigo, Mylan, AstraZeneca, ANDAs for topical patches
FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission

The US Food and Drug Administration (FDA) on Wednesday finalized its guidance on reducing the risk of hepatitis B virus (HBV) transmission via human cells, tissues and cellular and tissue-based products (HCT/Ps) by screening donors with nucleic acid tests (NAT).

Categories: Biologics and biotechnology, Blood, Human cell and tissue, News, US, FDA Tags: Nucleic acid testing, NAT, Hepatitis B, HBV
European Regulatory Roundup: Clinical Trial Delays Prompt EMA to Consider Revising Guidance (18 August 2016)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: Biologics and biotechnology, Drugs, Clinical, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, Submission and registration, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, clinical trial guidance, EFPIA, Novo Nordisk, HTA
Regulatory Recon: Medtronic Warns Doctors After 19 Deaths Reported; China to Invest $1B in US Biotech Site (18 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market?

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare.

Categories: Drugs, Business Skills, Government affairs, Quality, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: pharmaceutical patents, pharmaceutical IP, generic drugs, ANDA approval process
FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe

The US Food and Drug Administration (FDA) on Wednesday said it is maintaining its recommendation against the use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors (AERs) to clean duodenoscopes after finding the reprocessors were not adequately validated last November.

Categories: Medical Devices, Crisis management, Postmarket surveillance, News, US, FDA Tags: Endoscope, Duodenoscopes, Custom Ultrasonics', Superbug Outbreak, CRE, Recall
Regulatory Recon: FDA Advisers in Favor of Over-the-Counter STI Diagnostics; Report Claims PCSK9 Drugs Could Add $120 Billion to Annual Health Spending (17 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
European Commission Offers Guidance on Standalone Software as a Medical Device or IVD

The European Commission is offering guidance for device companies and other stakeholders trying to determine if their standalone software should be considered a medical device, in vitro diagnostic (IVD) or neither.

Categories: Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, Europe, EC Tags: standalone software as a medical device, European Commission guidance
FDA Warns 14 International Medical Device Companies

The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines.

Categories: Medical Devices, News, US, Europe, China, Latin America and Caribbean, CDRH Tags: Quality System Regulation, Medical Device Reporting, Corrective and Preventative Action, CAPA, Warning Letter
Regulatory Recon: Vertex Stops Cystic Fibrosis Combination Trial After No Benefit Found; Aurinia Lupus Drug Meets Endpoint Despite 13 Patient Deaths (16 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
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