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 Officials Offer Advice on Efficient Orphan Drug Development

A group of top US Food and Drug Administration (FDA) officials shared insights on how drugmakers can be more efficient when developing treatments for rare diseases, according to comments on Tuesday at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC.

Categories: Biologics and biotechnology, Drugs, Orphan products, Clinical, News, US, FDA Tags:
Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, stem cells, black triangle
ICH Transparency: New Info on Funding, Expert Working Groups

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, Asia, ICH Tags: ICH funding, E9, E11, S5
Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System

The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay.

Categories: Drugs, Reimbursement, News, US Tags: pharmaceutical pricing, Senate HELP committee, PhRMA
Regulatory Recon: J&J Halts Two Drugs in Development; Novartis to Close Colorado Manufacturing Site (17 October 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
EMA Plots Out Priorities to Deal With Brexit Uncertainties

The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU.

Categories: Biologics and biotechnology, Drugs, Crisis management, Postmarket surveillance, News, Europe, EMA, EC Tags: Brexit, EMA business continuity
Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement

In a setback for Allergan, four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday by the US District Court for the Eastern District of Texas. Allergan has said it will appeal the decision, but what might have a wider ripple effect was another order that raised questions about Allergan’s decision to pay to transfer the patents to a Native American tribe and prolong the launch of Restasis generics.

Categories: Biologics and biotechnology, Drugs, Due Diligence, Government affairs, News, US Tags: Restasis, Allergan, Saint Regis Mohawk Tribe
Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities

Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices.

Categories: Medical Devices, Clinical, News, US, FDA Tags: Patient Engagement, PEAC
Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

Categories: Biologics and biotechnology, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM
Regulatory Recon: FDA Reviewers Find Novo's Semaglutide Effective Ahead of Advisory Committee; GSK's Shingles Vaccine Gets First Approval in Canada (16 October 2017)

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
EMA Revises Reflection Paper on Pediatric Extrapolation

The European Medicines Agency (EMA) on Friday released an updated draft reflection paper for public consultation detailing the agency's framework for pediatric extrapolation in drug development.

Categories: Biologics and biotechnology, Drugs, Clinical, Preclinical, News, EMA, ICH Tags: Pediatric Extrapolation
EMA Responds to BMJ Article Questioning Benefits of Recent Cancer Drug Approvals

As more cancer drugs are approved and prices continue to rise, questions have circulated on whether these drugs are extending patient survival or improving quality of life (QoL).

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, US, Europe, FDA, EMA Tags: cancer drug approvals, QoL, survival benefit
Health Canada Seeks to Update User Fees for Drug and Device Firms

Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data.

Categories: Biologics and biotechnology, Drugs, Veterinary products, Government affairs, Submission and registration, News, Canada, Health Canada Tags: pharmaceutical fees, medical device fees, Health Canada fees
Meeting With FDA After a CRL: Draft Guidance on What to Expect

The US Food and Drug Administration (FDA) on Friday released new draft guidance for industry on the 30-minute post-complete response letter (CRL) meetings between FDA and abbreviated new drug application (ANDA) applicants to help clarify deficiencies.

Categories: Generic drugs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: CRL, complete response letter, draft guidance
Regulatory Recon: House Ethics Report Says Congressman May Have Violated Rules With Australian Biotech Investment; NICE Backs Opdivo for Head and Neck Cancer (13 October 2017)

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 Holds First Patient Engagement Advisory Committee Meeting

The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices.

Categories: Medical Devices, Clinical, News, US, FDA Tags: Patient Engagement, PEAC, Patient Engagement Advisory Committee, Patient Reported Outcomes, Patient Preference Information
PDUFA VI: FDA Explains User Fee Changes in Draft Guidance

The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible.

Categories: Drugs, Government affairs, Submission and registration, News, US, FDA Tags: PDUFA VI, prescription drug user fees, draft guidance
FDA Panel Votes Unanimously in Favor of Gene Therapy to Treat Rare Eye Disorder

Philadelphia-based Spark Therapeutics took its gene therapy before the US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee on Thursday and the panel voted 16 to 0 in favor of approving the subretinal injection, representing a major step forward for adeno-associated virus gene therapies.

Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Spark Therapeutics, gene therapy, retinal disease, Luxturna
When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance

The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted.

Categories: Generic drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, CDER Tags: 505(b)(2) application, ANDA, FDA draft guidance
Regulatory Recon: Merck Ends Development of CETP Inhibitor; NIH to Team Up With 11 Drugmakers for Immunotherapy Research (12 October 2017)

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
European Regulatory Roundup: Brexit Sparks Hiring Drive at Danish Medicines Agency (12 October 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, Europe, EMA, EC Tags: European Regulatory Roundup, Brexit
340B: Health System Execs Push Back on Narrowing of Drug Discount Program

The House Energy & Commerce's subcommittee on Oversight and Investigations on Wednesday discussed the federal 340B drug discount program, which provides participating hospitals and other medical providers deep discounts on outpatient drugs. 

Categories: Drugs, Government affairs, Reimbursement, News, US Tags: 340B program, drug discounts, pharmaceutical companies
REMS Format and Content: FDA Offers Draft Guidance

The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics.

Categories: Drugs, Labeling, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: REMS, REMS document, FDA draft guidance, GDUFA II
Regulatory Recon: Philips to Discontinue US Production of Some Defibrillators; Lupin Buys Symbiomix in $150M Deal (11 October 2017)

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
DTC Drug Ads: New Study Finds Perception of Risks Diluted by Lengthy Side Effects List

A study on direct-to-consumer (DTC) drug advertising published Monday in Nature Human Behavior finds that consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed.

Categories: Drugs, News, US, FDA, Advertising and Promotion Tags: Direct-to-Consumer, Drug Advertising, Side Effects, Risk
« 1 2 3 4 5  ... »