Drugs
A 6/13-17 FDA inspection at Sekisui Medical Co., Tokyo, Japan, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/8 Warning Letter. Specific deviations included: * failing to maintain complete data derived from all laboratory tests conducted to ensure compliance with
FDA Policy/General
The Federal Trade Commission (FTC) has announced a new “Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs.” The policy statement was developed based on a 2015 FTC workshop that examined how such drugs are marketed to consumers. According to the policy statement, FTC plans to
FDA Policy/General
[Analysis by Angi Robinson and Juliet Moritz*] Anyone who works in drug development will tell you this is a business of longshots. More than 90% of the compounds that reach clinical testing fail, and many more never make it that far. Add to those long odds the enormous time and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Morton Drug Company (dba Morton Long Term Care) Neenah, WI (10/26): FDA investigators inspected the facility 12/2015 and observed serious deficiencies in the firm’s practices for
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a new information collection related to an anti-tobacco campaign. The notice proposes s the creation of a cohort of cigarette smoking adults between the ages of 25 and 54 for the evaluation of FDA’s point of sale tobacco education
FDA Policy/General
Federal Register Notice: FDA has issued a debarment order against Paul S. Singh for providing services in any capacity to a person that has an approved or pending drug product application. The order is based on Singh haven been convicted of a felony under federal law related to his insertion
FDA Policy/General
FDA may be forced to lower its approval standards under the Trump administration, according to former Pfizer Global Research and Development president and Forbes contributor John LaMattina. Writing in a recent article, LaMattina takes a cue from in president-elect Donald Trump’s recent release of his First 100 Days
FDA Policy/General
Federal Register Notice: FDA has withdrawn two proposed rules published over five years ago because they are outdated. One rule is entitled “Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation.” The other is entitled “Crabmeat;
FDA Policy/General
Federal Register Notice:FDA has issued a debarment order against Edward Manookian (also known as Ed Manning) based on a finding that he was convicted of felonies under federal law for conduct relating to marketing and distributing unapproved drugs in the U.S. Manookian was the president and owner of
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an OMB submission to extend an information collection on the “Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-based Deviations in Manufacturing.” To view the notice, click here.
FDA Policy/General
Former FDAer Wayne Pines, now Apco president of healthcare, says he expects that under President Donald Trump FDA will be similar in nature to the agency it is today, but with new leadership. In a brief video, Pines outlines three impacts he believes the election results will have on FDA:
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an OMB submission to extend an information collection on reporting and recordkeeping requirements for manufacturers and distributors of electronic products. The requirements are outlined under the agency’s electronic product radiation control program, including the development, issuance, and administration of performance standards
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.” The document provides a specific labeling recommendation to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made due to a risk of tissue
FDA Policy/General
[Analysis by Jim Dickinson and David McFarland] Notwithstanding president-elect Donald Trump’s failure to publish a written policy platform, objective assessments of his public statements lead us to expect major changes in the way FDA does business with its regulated industries after his administration takes over in January. Actually,
FDA Policy/General
Federal Register Final Rule. FDA has amended certain regulations relating to citizen petitions, petitions for stay of actions and the submission of documents to the agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act that implement a congressional
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Non-Inferiority Clinical Trials to Establish Effectiveness.” The document discusses the appropriate use of such study designs to provide evidence on the effectiveness of a drug or biologic. It says that a non-inferiority design is usually used because a
FDA Policy/General
FDA has denied a ProbioTech petition filed in April that asked the agency to change the definition of a dietary supplement under the Dietary Supplement Health and Education Act and to treat probiotic suppositories the same as oral probiotic dietary supplements. The petition says that probiotics that are not in
Drugs
Consumers visiting branded prescription drug Web sites may misinterpret information learned from clicking on disease awareness Web sites shown on the drug site. That’s the conclusion of a study reported in the Journal of Health Communications that was conducted by CDER staff and other researchers. The researchers found that
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Innovative Compounding Pharmacy Folsom, CA (6/20). FDA investigators conducted a 4/2015 inspection after receiving an adverse event reportedly experienced by a patient who received a domperidone product
FDA Policy/General
Federal Register Final Rule: FDA has issued a final rule to amend the regulations to reflect organization change in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency’s regulations. To view the notice, click
FDA Policy/General
Federal Register Notice: FDA has established a public docket to collect comments related to a proposed Study Data Standardization Plan template. The template was developed by a working group under an ongoing collaboration with the Pharmaceutical Users Software Exchange, an independent, non-profit consortium addressing computational science issues. The template
Drugs
FDA is considering industry and advertiser proposals to allow links to risk information in promotional activities on character space-limited social media platforms like Twitter. It has announced new studies being designing to address the question of whether substantive risk information on such platforms is effective in communicating risks when