Pfizer extended dating

How does FDA handle expiration dating challenges?

Another way FDA can approach expiration dating challenges is through FDA’s expiration dating extension authority under section 564A (b) of the FD&C Act, which was established by PAHPRA in 2013.

Did Pfizer try to withhold trial data for 75 years?

With the release of Pfizer trial data — which they tried to withhold for 75 years — additional problems suggestive of fraud and data manipulation are coming to light

How to extend the expiration date of a drug product?

Expiration Dating Extension 1 Approaches to Drug Product Expiration Date Extensions. The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term ... 2 MCM Expiration Dating Extensions. ... 3 Additional Information. ...

How many Pfizer documents have been released by the FDA?

Among the tens of thousands of Pfizer documents released by the FDA so far, we now also have clear evidence of harm.

How are expiration dates established in the FDA?

2. How are expiration dates established? FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug.

Why do drug labels have expiration dates?

Drugs, including those that are both drugs and cosmetics, must be tested for stability (see the regulations at 21 CFR 211) and are required to have expiration dates printed on the labels. Manufacturers must make sure their drug products are safe and effective until their expiration dates.

Can a manufacturer extend the expiration date of a drug product?

The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved in the NDA or ANDA.

Can FDA extend the expiry date of MCMs?

Before PAHPRA, the distribution, dispensing, or use of products with extended expiry, and any related labeling adjustments, were possible through an EUA or FDA enforcement discretion. PAHPRA provides FDA with the explicit authority to extend the expiration dating of eligible FDA-approved MCMs stockpiled for use in CBRN emergencies.

How many documents does the FDA have to release?

In a January court order, U.S. District Judge Mark Pittman of the Northern District of Texas required the FDA to release around 12,000 documents immediately, and then 55,000 pages a month until all documents are released -- totaling more than 300,000 pages.

What does the FDA’s 80k-page document cache include?

The 80,000-page document cache released May 2 by the U.S. Food and Drug Administration (FDA) includes an extensive set of Case Report Forms (CRFs) from Pfizer trials conducted at various locations in the U.S.

How big is the underreporting problem at Pfizer?

From the Pfizer document: “Reports are submitted voluntarily, and the magnitude of underreporting is unknown.

Is Pfizer hiding adverse events from regulators?

“Pfizer claims that 0.5% of placebo recipients suffered a serious adverse event compared to 0.6% in the vaccine group. This is how these events were obscured.” The extant body of evidence indicates Pfizer “is hiding critical information from regulators,” Setty said: