US EditionFDA Suspends New Application Fees - BusinessWorld Online
- Following an increase in licensing fees for drug distributors in December 2024, the FDA announced a temporary halt on implementing recently introduced charges related to registering and evaluating medical products, impacting approximately 3,000 outstanding applications in the Philippines.
- The suspension followed industry concerns about fee increases without sufficient consultation and calls for legislation to support domestic medicine production and streamline regulatory processes.
- FDA Director Paolo S. Teston briefed the House, highlighting that slow permit processing raises medicine prices and promising proposed solutions to clear application backlogs.
- Separately, the FDA mandated Pfizer and Moderna update COVID-19 vaccine labels to warn of myocarditis risks in males aged 16-25, citing a Lancet study showing 60% with heart injury markers five months after diagnosis.
- This action ended a 13-month delay, raising transparency and long-term safety questions, especially for young males, and prompting the FDA to pledge stronger monitoring amid calls for public candor.
13 Articles
13 Articles
FDA suspends new application fees - BusinessWorld Online
THE Food and Drug Administration (FDA) said it suspended the new registration and assessment fees for medical products after legislators said they were modified without sufficient consultation. In a briefing at the House of Representatives, FDA Director-General Paolo S. Teston said the recommendation to suspend the new fees has been conveyed to Health Secretary Teodoro J. Herbosa, and will take effect after he gives his approval. “After due deli…
FDA Orders Covid ‘Vaccine’ Makers to Warn Public About Heart Damage Risk
The United States Food and Drug Administration (FDA) has ordered pharmaceutical giants Pfizer and Moderna to issue warnings that their Covid mRNA "vaccines" carry a high risk of heart damage, particularly for young men. The post FDA Orders Covid ‘Vaccine’ Makers to Warn Public About Heart Damage Risk appeared first on Slay News.
Todayville
LifeSiteNewsFDA says Pfizer, Moderna must expand warnings for COVID shots to young men
From LifeSiteNews Pfizer and Moderna must warn young men ages 16-25 that their COVID shots are linked to heart diseases, the FDA said. The Food and Drug Administration (FDA) has expanded its warnings about the dangers of mRNA COVID jabs. “The Food and Drug Administration is telling Pfizer and Moderna to expand the warning labels on their COVID-19 vaccines about the risk of a possible heart injury side effect linked to the mRNA shots, primarily i…
FDA Takes Action Against Third-Party Testing Labs Over Falsified Data
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid data. The action represents a firm response to data integrity breaches that could undermine medical device safety and disrupt the global supply chain. The letters, sent to Mid-Link Technology Testing Co., Ltd. in Tianjin and Sanitation & Environment …
Coverage Details
Bias Distribution
- 60% of the sources lean Right
To view factuality data please Upgrade to Premium
Ownership
To view ownership data please Upgrade to Vantage
