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The FDA has abruptly withdrawn a notice that was scheduled to be published in the Federal Register (FR) Tuesday, announcing a sharp increase in the fees for drugmakers under the Prescription Drug User Fee Act (PDUFA). Read More
Monoclonal antibody cocktails could be a useful alternative to rabies immunogloblin (RIG) when that’s in short supply and to avoid the risk of bloodborne contaminants, the FDA said in a new guidance for developers of anti-rabies antibody cocktails. Read More
The Federal Trade Commission (FTC) has withdrawn the last count in its complaint against drugmaker AbbVie after the Supreme Court declined to review a ruling that the drugmaker used sham litigation to illegally maintain a monopoly on its testosterone drug AndroGel. Read More
Emergent BioSolutions, which botched 75 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine, has said publicly for the first time that it has gotten records requests from a slew of federal investigators related to its COVID-19 contracts. Read More
Developing a good working relationship with your regulatory project manager (RPM) at the FDA is “the single most important thing you can do” to improve communication during a regulatory review, an agency official said at the FDA’s Regulatory Education for Industry Annual Conference. Read More
The FDA issued an advisory to drugmakers about the risk of bacterial contamination of non-sterile water-based drug products by Burkholderia cepacian (BCC). Read More
The FDA sent a warning letter to Round Rock, Texas-based Davati Medical Supply instructing it to stop marketing an unapproved quadrivalent influenza vaccine. Read More
The FDA added some clarifications in a final guidance for sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on submitting field alert reports (FARs), reminding them that FAR requirements apply to all products under an NDA or ANDA including positron emission tomography drugs, designated medical gases, and combination products containing a drug constituent part. Read More
The FDA explained in a new Manual of Policies and Procedures (MAPP) how generic drug sponsors can get their applications approved even if the submission coincides with labeling changes to the reference drug. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a new quality guideline for sponsors of drug-device combination products that will go into effect on Jan. 1. Read More
The House Energy and Commerce Committee wants Acting FDA Commissioner Janet Woodcock to explain how the agency plans to address the backlog of nearly 8,000 inspections accumulated during the pandemic as lawmakers worry about the potential impact on the agency’s drug reviews. Read More