Why FDA Will Have Difficulty Regulating Marijuana
The FDA does an admirable job overall of protecting the public from defective foods, drugs and devices. But the recent federal rescheduling of marijuana, which was confirmed by the president recently, will pose challenges to the FDA. The idea is to move cannabis from Schedule I, which features drugs without an accepted medical use, such […]
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Zentalis Shares Drop 30% After FDA Puts Partial Hold on WEE1 Drug
FDA has put three trials of the WEE1 candidate by Zentalis on a partial hold after two deaths that are alleged to have been caused by sepsis. The deaths happened during the Phase 2 DENALI clinical study. The purpose of the study was to evaluate the synthetic lethal WEE1 inhibitor azenosertib in people with ovarian […]
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FDA Blasts Laurus Synthesis With Untitled Letter
This month, FDA, which delivered an FDA 483 to India’s Laurus Synthesis in January, followed up that regulatory rebuke with an untitled letter that detailed the company’s problems with its QC unit and improper equipment cleaning. An untitled letter deals with violations that do not rise to the level of a warning letter, but should […]
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FDA Warning Letter Delivered to Cue Health in May 2024
Cue Health recently slashed 49% of its staff, but the hits keep on coming for the medical device company. FDA sent Cue Health an FDA warning letter this month regarding the firm’s Emergency Use Authorized COVID-19 test. In a press release, FDA stated that it warns caregivers, healthcare providers, and home test users to not […]
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Companies Aren’t Required To Respond To FDA 483s
A common question from drug and device manufacturers is how to respond to an FDA 483 or warning letter. Many employers think that the company has to respond to the FDA citation within 15 days, but this isn’t true, according to Gina Brackett, who is the director of compliance at the Office of Medical Device […]
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Eugia Hit With Another 483 in Less Than a Year
Sterile drug manufacturing company Eugia stays under major FDA scrutiny, as the division of Aurobindo has been hit with its fifth FDA 483 since the end of 2023. The firm’s latest criticism from FDA is related to an April and May cGMP audit. The sterile drug manufacturer received seven agency observations. Most of the 483 […]
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Dr. Reddy’s Laboratories Slapped With 483 After FDA Preapproval Inspection
Dr. Reddy’s Laboratories has been hit with another 483 for problems with its production facilities. FDA performed a preapproval inspection at the firm’s formulations manufacturing plant which is known as FTO 11. Dr. Reddy’s told the press that the agency gave them a two-item 483 that focused on subpar manufacturing standards. The FDA inspection took […]
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FDA Commissioner Wants To Revamp The Evidence Generation System
FDA Commissioner Rob Califf said last week that he wants to combat scientific misinformation and create new ways to increase the use of the evidence generation system that FDA relies on to make its drug approval decisions. Califf referred to the agency as a decision-making machine and an organization that is ‘a referee that plays […]
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FDA User Fee Bill Deadline Passes; FDA Reviewers May Be Laid Off
The fight over what should be included in the latest round of FDA user fee legislation – the money from the pharma industry that pays for drug and biologic reviews at the agency that must be reauthorized every five years – is reaching a climax this month. Congress is attempting to meet a recess deadline […]
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EMA Planning Transition To Reviewing Raw Clinical Data
FDA often talks about the fact that it’s the only global pharma regulator that reviews raw clinical data, meaning the data of individual patients during its pharmaceutical application reviews. This often allows FDA to avoid what could be misleading or biased data offered by a drug sponsor. This month, the European Medicines Agency (EMA) is […]
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