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Critics call out HHS secretary Robert F. Kennedy Jr.’s recent Make America Healthy Again report for citing allegedly nonexistent scientific studies.

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FDA releases a draft guidance entitled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.”

LATEST NEWS

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MAHA Report Questioned on ‘Nonexistent Science’

Critics call out HHS secretary Robert F. Kennedy Jr.’s recent Make America Healthy Again report for citing allegedly nonexistent scientific studies.

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Guide on Bioequivalence for Immediate-Release Drugs

FDA releases a draft guidance entitled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.”

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Aurolife NC Drug Plant Hit With Form-483

FDA issues Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited significant GMP deficiencies.

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Group Seeks Warnings on Nuvigil, Provigil

Public Citizen petitions FDA to contraindicate the use of Provigil (modafinil) and Nuvigil (armodafinil) during pregnancy because they are allegedly linked to major birth defects.

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Animal Drugs

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medical-devices
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GSK Plans for Antibiotic NDA in 2nd Half

GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...

medical-devices
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Prothena Scraps Birtamimab After Phase 3 Miss

Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to meet primary or second...

medical-devices
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Interchangeability for Celltrion’s Humira Biosimilar Expanded

FDA grants an expanded interchangeable designation for Celltrion’s Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVie’s Humira.

medical-devices
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Accelerated Approval Works: Friends of Cancer Research

A Friends of Cancer Research online data analysis shows the FDA accelerated approval program is working as designed to speed innovative drugs to the m...

Biologics

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medical-devices
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HHS Nixes Moderna Bird Flu Vaccine Funding

HHS terminates a late-stage grant award to Moderna for developing a vaccine candidate targeting the H5 bird flu.

medical-devices
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Congressmen Hit FDA Covid Vaccine Limit

Eight congressional Democrats call on FDA to eliminate its new limits on Covid-19 vaccines.

medical-devices
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Covid Vaccine Nixed for Children/Pregnant Women

HHS removes Covid-19 vaccine recommendations for healthy children and healthy pregnant women from CDC’s recommended immunization schedule.

medical-devices
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FDA Backs Covid JN.1-Lineage for Next Boosters

FDA advises Covid-19 vaccine makers to formulate their products to match the currently circulating JN.1-lineage and preferentially using the LP.8.1 Co...

FDA General

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medical-devices
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House Democrats Want Answers on HHS Staff Cuts

Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secretary Robert F. Kenn...

medical-devices
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To Make FDA Great Again, Impeach RFK Jr.

To “make FDA great again,” FDA Webview editor James G. Dickinson urges Congress to impeach HHS secretary RFK Jr. on four counts of misleading lawmaker...

medical-devices
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Congress Should End Government Layoffs: Professor

Harvard University health policy professor Benjamin Sommers calls on Congress to stand up against cuts in the federal workforce that he says are hurti...

medical-devices
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Judge Blocks Mass Federal Layoffs Pending Appeal

A federal judge extends by two weeks a preliminary injunction halting the Trump administration’s plans for further reductions in force at FDA and 21 o...

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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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MAHA Report Questioned on ‘Nonexistent Science’

Critics call out HHS secretary Robert F. Kennedy Jr.’s recent Make America Healthy Again report for ...

motusgi
Read More
Guide on Bioequivalence for Immediate-Release Drugs

FDA releases a draft guidance entitled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage ...

motusgi
Read More
Aurolife NC Drug Plant Hit With Form-483

FDA issues Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manuf...

motusgi
Read More
Group Seeks Warnings on Nuvigil, Provigil

Public Citizen petitions FDA to contraindicate the use of Provigil (modafinil) and Nuvigil (armodafi...

Marketing

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Attorney Warns: FDA Watching Professional Promotion

Attorney Nathan Downing says medical product companies should review their professional promotions a...

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RFK Jr. Attacks ‘Corrupt’ Drug Firms and DTC Ads

In a 5/27 podcast interview, HHS secretary Robert F. Kennedy Jr. continues his verbal assault agains...

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Sen. Durbin Queries FDA on Drug Promo Staff Cuts

Senator Dick Durbin (D-IL) asks FDA commissioner Marty Makary how CDER’s Office of Prescription Drug...

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FDA Warns Sarfez About Soaanz Promotional Materials

The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materia...

Medical Devices

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Breakthrough Status for Artificial Heart

FDA grants BiVACOR a breakthrough device designation for its titanium Total Artificial Heart.

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Multiple Issues at Germany’s DRG Instruments

FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not...

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FDA Publishes 2 Q-Submission Guidances

FDA publishes two guidances relating to the CDRH/CBER Q-submission process.

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Quality System Issues in Spain’s Sedecal Inspection

FDA warns Madrid, Spain-based Sedecal about Quality System violations in its production of mobile di...