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Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consumer radio and TV ads would receive significant pushback and would change the advertising landscape if finalized.

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Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all that FDA and the medical device industry have agreed to.

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FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consumer radio and TV ads would receive significant pushback and would change the advertising landscape if finalized.

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FDA, Industry Have MDUFA 6 Agreement in Principle

Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all that FDA and the medical device industry have agreed to.

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FDA Cites Cliantha Research on Data Integrity, Quality Unit

FDA investigators cite contract research organization Cliantha Research over data integrity, documentation and clinical research deficiencies following a recent inspection.

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Petition Urges FDA to Create Pathway for Brain-Computer Interfaces

A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand human sensory perception beyond the natural limits of human vision.

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Animal Drugs

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medical-devices
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Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

medical-devices
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FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA authorizes Felix Pharmaceuticals’ generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

Biologics

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medical-devices
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Dyne Therapeutics BLA for Duchenne Muscular Dystrophy

FDA accepts for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular dystrophy amenable ...

medical-devices
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Blood Donor Screening in an Ebola Outbreak

FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in response to an Ebola ...

medical-devices
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Former CDC Official Alleges Political Interference In Vaccine Policy

During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no longer defend its sci...

medical-devices
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FDA Accepts Replimune's Resubmitted BLA for Advanced Melanoma

FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolu...

FDA General

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medical-devices
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FDA May Go Months Without Senate-Confirmed Commissioner: Analysis

An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate eff...

medical-devices
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FDA Reform Requires a ‘Whole-of-System’ Strategy: Editorial

A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only way to successfully...

medical-devices
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House Passes FDA Modernization Act 3.0 for Reducing Animal Testing

The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adopti...

medical-devices
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FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says

In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are increasingly extending ...

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Federal Register

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FDA Moves to Cement Complete Response Letter Transparency Policy

FDA looks to formalize one of its most significant transparency initiatives in decades: the public r...

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

Human Drugs

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FDA Cites Cliantha Research on Data Integrity, Quality Unit

FDA investigators cite contract research organization Cliantha Research over data integrity, documen...

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CGMP Issues at India’s Shimoga Chemicals

FDA warns India’s Shimoga Chemicals about CGMP deviations in its production of active pharmaceutical...

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No Informed Consent in Alembic Trial

FDA warns India’s Alembic Research Center that it failed to obtain informed consent for an in vivo b...

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Acadia Gets Fast Track for Alzheimer’s Psychosis Drug

FDA awards Acadia Pharmaceuticals a Fast Track designation for remlifanserin, an investigational, hi...

Marketing

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FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within th...

motusgi
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FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respi...

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Friendly Accelerated Approval Disclosures Improve Drug Understanding: Study

A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the ...

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DTC Advertising Industry Braces for Potential End of Adequate Provision

DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provi...

Medical Devices

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FDA, Industry Have MDUFA 6 Agreement in Principle

Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitm...

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Petition Urges FDA to Create Pathway for Brain-Computer Interfaces

A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer ...

motusgi
Read More
FDA Issues Early Alert on Baxter IV Administration Sets

FDA issues an Early Alert warning healthcare providers about a potentially high-risk issue involving...

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Class I Recall of Bolton Medical’s Relay Pro Thoracic Stent Graft System

Bolton Medical recalls its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment fai...