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.

Three FDA Final Rules Slated for Release in May

Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products.

Categories: Biologics and biotechnology, Combination products, Drugs, Medical Devices, Clinical, Compliance, Government affairs, News, US, FDA Tags: device trial data, combo product safety, pharmaceutical manufacturing facilities
FDA Revises Guidance on Special Protocol Assessments

The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and the US Food and Drug Administration (FDA) to discuss plans for clinical trials.

Categories: Clinical, Project management, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: SPA, special protocol assessments, clinical trial meetings with FDA
Drug Safety Reports Still Uninformative, FDA Officials Say

Most expedited safety reports for investigational new drugs (INDs) are uninformative, despite recent efforts to improve the quality of such reports, FDA officials wrote in a recent research article.

Categories: Biologics and biotechnology, Drugs, Clinical, News, US, FDA Tags: Investigational new drug application, IND, expedited safety reports
Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements.

Categories: Drugs, Government affairs, News, US, FDA, Advertising and Promotion Tags: pharma ads, efficacy claims in pharmaceutical advertising, FDA regulation of pharma ads
Regulatory Recon: CRISPR Won't Help Sick Patients Soon; EU Device Regulation to Move Forward in June (4 May 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 Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Antipsychotic Label Updated With New Impulse-Control Side Effects

The US Food and Drug Administration (FDA) on Tuesday warned that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of Otsuka’s antipsychotic drug aripiprazole (brand names include Abilify, Abilify Maintena, Aristada) or generic versions from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals.

Categories: Drugs, Labeling, News, US, FDA Tags: Abilify, impulse control, FDA safety communications
FDA Amends Regulations on General Biologic Standards for First Time Since 1977

The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: general biologic standards, biologic regulations, FDA final rules
FDA Calls for Head-to-Head Trials in Revised Draft Guidance on Hepatitis C Drugs

The US Food and Drug Administration (FDA) on Tuesday released a revised version of its draft guidance on direct-acting antiviral (DAA) Hepatitis C virus (HCV) drugs, which calls on sponsors to conduct head-to-head Phase III studies for drugs in development.

Categories: Biologics and biotechnology, Drugs, Clinical, Postmarket surveillance, Preclinical, News, US, FDA Tags:
Asia Regulatory Roundup: CFDA Proposes Sourcing Requirements for Drug, Device Companies (3 May 2016)

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

Categories: Biologics and biotechnology, Drugs, Crisis management, Compliance, News, Asia, CFDA, CDSCO Tags: drug supply chain, medical device export certificates, China and Taiwan clinical trials, Asia Regulatory Roundup
Regulatory Recon: Cancer Drug Prices Continue to Rise Despite Competition, CFDA Releases 186 Device Standards (3 May 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
Confusion Pushes FDA to Change Antidepressant’s Brand Name

The US Food and Drug Administration (FDA) on Monday approved a brand name change for Takeda’s antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from confusion with AstraZeneca’s blood-thinning medicine Brilinta (ticagrelor).

Categories: Compliance, Labeling, Regulatory intelligence, News, US, FDA, Advertising and Promotion Tags: brand name change, medication errors, Brinellix, Brilinta
EMA Finalizes Process Validation Guidance

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances.

Categories: Biologics and biotechnology, Manufacturing, Regulatory strategy, News, Europe, EMA, ICH Tags: Process validation, process development, process evaluation, process verification
USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries

The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four Asian countries.

Categories: Biologics and biotechnology, Drugs, Compliance, Distribution, News, US, Europe, Asia, Middle East Tags: US trade representative, counterfeit drugs, Indian drug counterfeits, US trade partners for pharmaceuticals
USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries

The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four Asian countries.

Categories: Biologics and biotechnology, Drugs, Crisis management, Compliance, Government affairs, News, US, Europe, Asia, Latin America and Caribbean, Middle East, Oceania Tags: US trade representative, counterfeit drugs, Indian drug counterfeits, US trade partners for pharmaceuticals
Genomic Data and Drug Development: EMA Offers New Draft Guidance

As the push for personalized medicine garners more attention, the European Medicines Agency (EMA) on Monday released new draft guidance to provide industry with more insight on how to identify and understand genomic factors that influence drug responses.

Categories: Biologics and biotechnology, Clinical, Crisis management, Government affairs, Quality, News, Europe, EMA Tags: pharmacogenomics, liquid biopsy, cancer drugs and genomics, EMA guidance
Regulatory Recon: FDA Approves Acadia's Nuplazid to Treat Parkinson's Hallucinations; France Gets G7 to Weigh in on Drug Pricing (2 May 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
FDA Slowly Chips Away at ANDA Backlog

Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday.

Categories: Generic drugs, Compliance, Due Diligence, Government affairs, Submission and registration, News, US, CDER Tags: ANDA backlog, generic drug applications, FDA generic approvals
Regulatory Recon: Zika Impact Worse Than Expected; Questions on Cancer Moonshot Coordination (29 April 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 Reviewing Indian CRO Semler After FDA Warns of Data Integrity Issues

The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility.

Categories: Generic drugs, Clinical, Ethics, Preclinical, Submission and registration, News, Europe, India, FDA, EMA, WHO Tags: Data integrity, Notice of Concern, Semler
FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator.

Categories: Active pharmaceutical ingredients, Drugs, Crisis management, Compliance, Ethics, Government affairs, Manufacturing, Quality, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, FDA, Health Canada Tags: Indian drug manufacturing, Indian API manufacturing, Polydrug Laboratories, product quality complaints, FDA warning letters
Public Citizen Sues FDA Over Redacted Advisory Committee Info

The consumer advocacy group Public Citizen is suing the US Food and Drug Administration (FDA) in federal court over the agency's practice of redacting information in the curricula vitae (CV) of its advisory committee members.

Categories: Government affairs, News, US, FDA Tags: Public Citizen, Advisory Committee Members, Freedom of Information,
Device Supplier Settles Monopoly Allegations With FTC

UK-based Invibio, the first company to sell implant-grade polyetheretherketone (known as PEEK) to the world’s largest medical device makers for spinal and other medical implants, has agreed to settle Federal Trade Commission (FTC) charges that it violated federal antitrust law by using long-term exclusive contracts to monopolize the PEEK market.

Categories: Medical Devices, Crisis management, Due Diligence, Distribution, Manufacturing, Regulatory strategy, News, US, Europe, FTC, Business and Leadership Tags: PEEK, medical device suppliers, polymer suppliers, Invibio, Evonik, Solvay
CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit adverse events linked to vaccines.

Categories: Biologics and biotechnology, Crisis management, Ethics, Government affairs, Postmarket surveillance, News, US, CBER Tags: vaccine adverse events, vaccine reporting, electronic reporting of adverse events
Regulatory Recon: Abbott, AbbVie Announce Billion Dollar Acquisitions; New Bill Would Overhaul Opioid Approval Process (27 April 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 Regulatory Roundup: EMA to Allow Patient-Reported Outcomes in Oncology Trials (28 April 2016)

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

Categories: Biologics and biotechnology, Drugs, Clinical, Regulatory intelligence, Submission and registration, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, MHRA, EMA, oncology trials
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