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.

Legislators Ask FDA to Explain How it Missed Presence of Smallpox Vials for Decades

The recent discovery of vials of smallpox and other potentially deadly pathogens at a facility controlled by the US Food and Drug Administration (FDA) raises "very serious questions" about federal regulators' capabilities and compliance with federal law, legislators said in a letter to FDA Commissioner Margaret Hamburg and other federal officials.

Categories: Audit, Crisis management, Compliance, News, US, CBER Tags: Smallpox, Variola, Legislators, Letter, Margaret Hamburg, Audit
After Intense Scrutiny, FDA Set to Take Another Look at OTC Antiseptics

The US Food and Drug Administration (FDA) will soon hold a meeting regarding the safety and efficacy of non-prescription antiseptic products, just months after raising concerns about the products to manufacturers.

Categories: Over the counter drugs, Postmarket surveillance, News, US, CDER Tags: NDAC, Antiseptic, OTC, AdComm, Nonprescription Drug Advisory Committee
Regulatory Recon: Researchers Want FDA to Implement Clearer Drug Labels (28 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
Will FDA Soon Allow Drug Makers to 'Reserve' Drug Names?

Could a company with a good idea for a drug name "reserve" that name, preventing another company from using it or using another name similar enough to it to create confusion? While the idea has long been advanced by those in industry, the US Food and Drug Administration (FDA) now says it's willing to consider the idea as well, and is soliciting public input on the proposal.

Categories: Drugs, Labeling, News, US, CDER Tags: Drug Naming, Reserving Drug Name, Brand Name, Proprietary Name
FDA Issues Guidance on 'Substantial Equivalence' Process Used to Bring Devices to Market

The US Food and Drug Administration (FDA) has issued an extensive and long-awaited guidance document on its premarket notification program—also known as the 510(k) pathway—detailing how regulators will evaluate applications in order to determine "substantial equivalence."

Categories: In vitro diagnostics, Medical Devices, Regulatory strategy, Submission and registration, News, US, CDRH Tags: 510(k), Premarket Notification, Guidance, Final Guidance, Substantial Equivalence, Predicate, Split Predicate, Reference Device
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
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
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
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
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
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
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
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,
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
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
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
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
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