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.

Regulatory Recon: Court Backs FDA Stance on Antibiotics Regulation (25 July 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
Sandoz First Company to File for Biosimilar Approval in US Under New Pathway

Biopharmaceutical company Sandoz, a Novartis subsidiary, has announced that it has filed the first-ever biosimilar application in the US with the Food and Drug Administration (FDA) using its 351(k) pathway.

Categories: Biologics and biotechnology, Submission and registration, News, US, CDER Tags: Biosimilar, Biosimilarity, Follow-on Biologic, Sandoz, 351(k), First Biosimilar Filing in US
FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected

The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators.

Categories: Active pharmaceutical ingredients, Drugs, Audit, Compliance, News, US, China, CDER Tags: Import Alert, FDASIA, FDASIA Section 709, Delayed Inspection, Denied Inspection, Limited Inspection, Import Alert
Using Patient Safety Schemes to Delay Generic Drugs Costs Consumers Billions, Study Finds

A new report sponsored by the generic pharmaceutical industry claims that branded pharmaceutical companies are using Risk Evaluation and Mitigation Strategies (REMS) to great effect—just not the effect that regulators had intended.

Categories: Generic drugs, Submission and registration, News, US, CDER Tags: REMS, Risk Evaluation and Mitigation Strategies, Study, GPhA, Generic Drug
Regulatory Recon: BMJ Investigation Claims Pradaxa Data Withheld from Regulators (24 July 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
EMA Review of Emergency Contraceptives Short on Data, but Finds no Cause for Concern

EU regulators say that two emergency contraceptive drugs, levonorgestrel and ulipristal, remain effective for their prescribed purpose "regardless of bodyweight," placating some—but not all—concerns that the drugs might lose effectiveness when taken by women weighing more than 80kg (176 lbs).

Categories: Drugs, Postmarket surveillance, News, US, Europe, CDER, EMA Tags: Plan B, Norlevo, Leconorgestrel, Emergency Contraceptive, Levonelle, Ulipristal, Weight
Regulatory Recon: Indian Drug Regulator Called a 'Snake Pit of Vested Interests (23 July 2014)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

How can regulatory professionals use Twitter as a tool to collect regulatory intelligence? This articles explains the basics of Twitter, as well as 460 accounts that life science professionals can follow to get started and make the most out of the social media platform.

Categories: Regulatory intelligence, News Tags: Healthcare Social Media, Twitter, Social Media, Top Twitter Accounts, Top Twitter in Life Science, Top Twitter in Pharma, Top Twitter in Medical Device, Top Twitter in Biotech
Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in Warning Letter

Pharmaceutical compounders, take note: The US Food and Drug Administration (FDA) wants you to stop using laminated particleboard in your aseptic processing areas.

Categories: Drugs, Compliance, Quality, News, US, CDER Tags: Pharmaceutical Compounding, Compounding, Sterile Compounding, ISO 5, Cleanroom, Asceptic, Aseptic, Particleboard, Warning Letter
FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs

The US Food and Drug Administration (FDA) has released 37 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence.

Categories: Generic drugs, Clinical, News, US, CDER Tags: BE, Bioequivalence, Bioequivalence Standards
Nuclear Regulators Ease Burden on Some Medical Devices, Expediting New Trials

Sponsors of medical device products containing radioactive material may soon find it easier to bring the products to market under a newly proposed rule issued this week by the Nuclear Regulatory Commission (NRC).

Categories: In vitro diagnostics, Medical Devices, News, US Tags: NRC, Nuclear Regulatory Commission, Radioactive, SSRD, Sealed Source and Device Registry, Byproduct Material
Regulatory Recon: Should FDA Guidance on Mobile Apps be Made Permanent? (22 July 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
Regulatory Recon: UK Unveiling Device Safety Changes (21 July 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
Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media.

Categories: Prescription drugs, Labeling, News, US, CDER Tags: OPDP, Untitled Letter, Advertising, Marketing, Promotion, Phone Script, One-Click Rule,
Public Comment Period Opens on ISO 9001, Major Device Quality Standard

The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation.

Categories: In vitro diagnostics, Medical Devices, Manufacturing, Quality, News, ISO Tags: ISO 9001, QMS, Quality Management System, Consultation, International Standards Organization, ISO
After 'Arduous' Setbacks, FDA's Generic Drug Strategy Takes Shape in New Leadership

The US Food and Drug Administration's (FDA) long-awaited reorganization of its Office of Generic Drugs (OGD) is finally getting underway, the agency said in a statement today.

Categories: Generic drugs, News, US, CDER Tags: OGD, Office of Generic Drugs, Janet Woodcock, ORS, OB, OGDP, ORO, Super Office
ONC Director Defends Health IT Safety Center as it Struggles to Take Shape

In response to pressure from members of Congress, a group of federal health IT regulators is clarifying which authorities a proposed Health IT Safety Center would—and would not—have.

Categories: In vitro diagnostics, Medical Devices, News, US, FDA Tags: ONC, FDA, FDASIA, Health IT, Health IT Safety Center, Karen DeSalvo, House, Legislators, Energy & Commerce Committee
With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

A new draft guidance document issued this week by the US Food and Drug Administration (FDA) establishes best practices for the submission of safety reports related to the use of vaccines.

Categories: Biologics and biotechnology, News, US, CBER Tags: VAERS, Vaccine, ESG, Electronic Submission Gateway, ICSR
Ireland Considers Switching 12 Medicines to OTC Status

Ireland's Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it believes could safely be made available to consumers over-the-counter (OTC).

Categories: Over the counter drugs, News, Europe Tags: Ireland, OTC, Over-the-Counter, Rx-to-OTC Switch
Regulatory Recon: FDA's India Office Loses Leader (18 July 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
House Republicans Increase Pressure on FDA Proposal, Citing Agency's 'Dubious' Behavior

A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group.

Categories: Generic drugs, News, US, CDER Tags: Generic Drug, ANDA, CBE-0, Generic Drug Labeling Rule, House, Legislators
Spain Launches new Registry of API Manufacturers, Distributors, Importers

The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, import and distribution of pharmaceutical active ingredients in Spain.

Categories: Active pharmaceutical ingredients, Submission and registration, News, Europe Tags: Spain, API, Active Pharmaceutical Ingredient, AEMPS, Registration
Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out

How do teenagers and young adults interpret messages contained in direct-to-consumer pharmaceutical advertisements? The US Food and Drug Administration (FDA) wants to know, and is now moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising.

Categories: Drugs, News, US, CDER Tags: Study, DTC Advertising, Teenagers, Young Adults, Adolescents
FDA Facility Held Unknown Vials of Smallpox, Dengue, Q Fever and Other Deadly Diseases

The US Food and Drug Administration (FDA), just days after announcing that it had found decades-old vials of variola—the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month.

Categories: Biologics and biotechnology, Crisis management, News, US, CBER Tags: Smallpox, Variola, Q Fever, Dengue, Influenza, Rickettsia, Cold Storage
Regulatory Recon: FDA Won't Place Serious Warning on Testosterone Products (17 July 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
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