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A congressional commission on U.S.-China relations calls on Congress to authorize FDA to collect data from drug companies on where their drug components are made as part of an effort to reduce dependence on China for medicines.

latest-news

CBS News says the federal patent office is taking steps to slow challenges to innovator biologic drug patents by biosimilar drug makers, while FDA is working to make the biosimilar approval process faster and less costly.

LATEST NEWS

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FDA Needs More Data on China Drug Production: Report

A congressional commission on U.S.-China relations calls on Congress to authorize FDA to collect data from drug companies on where their drug components are made as part of an effort to reduce dependence on China for medicines.

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FDA, Patent Office at Odds on Biosimilars: CBS News Report

CBS News says the federal patent office is taking steps to slow challenges to innovator biologic drug patents by biosimilar drug makers, while FDA is working to make the biosimilar approval process faster and less costly.

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FDA Warns Indian API Maker Over Quality Lapses

FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP violations at the company’s active pharmaceutical ingredient plant in Bangalore.

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Petition Rejected on New Warnings for Surgical Mesh

FDA denies a citizen petition requesting that it warn patients about whether surgical mesh implanted off-label during cosmetic mastopexy procedures may interfere with breast cancer detection.

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Animal Drugs

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medical-devices
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Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

medical-devices
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10/9 Vaccines Panel to Recommend Flu Strain Selection

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...

medical-devices
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Capsida Pauses Gene Therapy Trial After Death

Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...

medical-devices
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Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Biologics

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medical-devices
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Promising Ziihera Data in Gastric Cancer Trial

Zymeworks reports that its HER2-targeted bispecific antibody Ziihera (zanidatamab-hrii) significantly improved outcomes for patients with HER2-positiv...

medical-devices
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FDA Approves First Interchangeable Perjeta Biosimilar

FDA approves Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentech’s Perjeta (pertuzumab), a HER2-t...

medical-devices
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Outlook Therapeutics BLA Resubmitted for Wet AMD

FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizu...

medical-devices
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Petition Urges FDA to Ease Oversight of Stem Cell Products

A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therapies.

FDA General

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medical-devices
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RFK Jr. reportedly Mulled Limiting Makary’s Authority

HHS secretary Robert F. Kennedy Jr. reviews options to scale back the operational role of FDA commissioner Marty Makary, including the possibility of ...

medical-devices
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FDA Previews Reforms as Pazdur Takes Over CDER

FDA commissioner Marty Makary and CBER director Vinay Prasad preview upcoming agency reforms during an FDA Direct podcast focused on the appointment o...

medical-devices
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Rising Concerns Over FDA Consistency, Transparency: Axios

An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening public confidence in...

medical-devices
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‘MAHA Summit’ to Hear from Vance, Kennedy, Makary

A MAHA Summit on 11/19 will hear from vice president JD Vance, HHS secretary Robert F. Kennedy, Jr., and FDA commissioner Marty Makary, among many oth...

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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FDA Needs More Data on China Drug Production: Report

A congressional commission on U.S.-China relations calls on Congress to authorize FDA to collect dat...

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FDA, Patent Office at Odds on Biosimilars: CBS News Report

CBS News says the federal patent office is taking steps to slow challenges to innovator biologic dru...

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FDA Warns Indian API Maker Over Quality Lapses

FDA issues a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered CGMP v...

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Multiple Violations in DermaRite Inspection

FDA warns North Bergen, NJ-based DermaRite Industries about CGMP, unapproved new drug, and misbrande...

Marketing

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FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

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Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

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Create ‘Drug Facts’ Box for DTC Ads: Column

Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers...

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WLF Wants End to FDA TV Ad ‘Crackdown’

The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising,...

Medical Devices

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Petition Rejected on New Warnings for Surgical Mesh

FDA denies a citizen petition requesting that it warn patients about whether surgical mesh implanted...

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What FDA Might Want in Chatbot Therapy for Depression

Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the ag...

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FDA OKs Companion Diagnostic for Endometrial Cancer Therapy

FDA approves Promega’s OncoMate MSI Dx Analysis System as a companion diagnostic for identifying end...

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Complying with QMSR ‘Critical Business Strategy’: Attorneys

Alston & Bird attorneys urge medical device companies to move quickly to prepare to implement FDA’s ...