FDA Policy/General
Tobacco Product Substantial Equivalence Rule Withdrawn 1/25 Federal Register notice: FDA has withdrawn a 1/21-posted final rule that provided additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also established general procedures FDA intends
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) has released charts showing program metrics for the first quarter of the 2021 Fiscal Year. The post shows statistics on the number and percentage of core initial promotional material reviews completed in 45 days in each of the three months, percentage of
FDA Policy/General
Some 29 advocacy groups, led by Public Citizen and Physicians for Responsible Opioid Prescribing, are urging the Biden administration not to appoint acting commissioner Janet Woodcock as commissioner of FDA. In a 1/27 letter to incoming HHS officials, the groups say that in her role as CDER director for
FDA Policy/General
Harvard University government professor David Carpenter and Yale School of Public Health assistant professor Gregg Gonsalves are urging President Joe Biden to choose former FDA principal deputy commissioner Joshua Sharfstein as the new FDA commissioner. Writing in a Stat News opinion piece, Carpenter and Gonsalves say they have interacted with
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Sage Moon Apothecary, Seal Harbor, ME (1/14): FDA has reviewed the company’s Web sites and determined that its products “Golden Milk Electuary-Mushroom Cocoa Blend,” “Golden Milk
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) says its regulatory attention in 2021 will focus on promotional materials involving high-risk drugs like opioids. “We want to make sure the promotional materials accurately convey the risks associated with these drugs, convey responsible use of opioids, and do not inadvertently
FDA Policy/General
Federal Register notice: FDA has withdrawn a 1/21-posted final rule that provided additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also established general procedures FDA intends to follow when evaluating SE Reports, including procedures
FDA Policy/General
Federal Register notice: FDA has withdrawn a 1/21-posted final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The withdrawal is in response to an ongoing review by the Biden Administration of regulatory
FDA Policy/General
New Tobacco Products Applications Guide Withdrawn Federal Register notice: FDA has announced the withdrawal of a draft guidance entitled Applications for Premarket Review of New Tobacco Products. The document is being withdrawn because the topics discussed in it are addressed in the final rule entitled “Premarket Tobacco Product Applications and
FDA Policy/General
HHS’s unprecedented overreach during the Trump Administration has drawn increased interest in making FDA an independent agency. “The durability and long-term effects of the department’s changes to FDA policy and its actions to limit the agency’s autonomy remain in question, but the public conversation about independence,
FDA Policy/General
Federal Register notice: FDA has announced the withdrawal of a draft guidance entitled Applications for Premarket Review of New Tobacco Products. The document is being withdrawn because the topics discussed in it are addressed in the final rule entitled “Premarket Tobacco Product Applications and Recordkeeping Requirements.” To view the notice,
FDA Policy/General
Federal Register notice: FDA has issued a final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule is intended to help ensure that PMTAs contain sufficient information for FDA to determine whether a
FDA Policy/General
Outgoing FDA commissioner Stephen Hahn said 1/19 that the agency does not support a memorandum of understanding (MOU) signed that day by Department of Agriculture (USDA) secretary Sonny Perdue and HHS assistant secretary Brett Giroir establishing a regulatory environment for agricultural animal biotechnology innovation. In a series of Tweets,
FDA Policy/General
Federal Register notice: FDA and HHS have revised proposal requests for reimporting insulin and the personal importation of prescription drugs that appeared in the 9/24/2020 Federal Register. Proposals submitted in response to the requests will be accepted and reviewed on a rolling basis, and until further notice. To
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to provide additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also establishes general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications
FDA Policy/General
As the transition of power concludes in Washington, DC and CDER director Janet Woodcock assumes temporary control of FDA until a new commissioner is appointed, we are reminded just how important an independent and a free-from-political-interference agency really matters. A Vanity Fair special report examines how former
FDA Policy/General
Federal Register Final Rule: The Regulatory Flexibility Act (RFA) requires agencies like FDA to publish plans to conduct periodic reviews of certain of their regulations. To further comply with the RFA and subsequent executive orders, and to ensure the department’s regulations have appropriate impacts, HHS is issuing the final
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Bodyhealth.com, Clearwater, FL (12/9/2020) An FDA review of the company’s Web site (www.bodyhealth.com) has determined that
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Data to Support Drug Product Communications as Used by the Food and Drug Administration,” (OMB Control Number 0910–0695). The collection supports agency outreach efforts, such as testing of communication messages in advance of a communication campaign.
FDA Policy/General
Three staff in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine of the University of Pennsylvania say FDA “cannot make decisions on the basis of science alone, and political considerations sometimes do have a role to play.” In an online letter to the editor
FDA Policy/General
In an interview less than 24 hours before he leaves office with the change in presidential administrations, FDA commissioner Stephen Hahn has acknowledged significant pressure from the White House over Covid-19 vaccines and treatments. “I heard loud and clear from the White House, President Donald Trump, and others, that
FDA Policy/General
20 Drug Determinations on ANDA Availability Federal Register notice: FDA has determined that 20 drug products (detailed below) were not withdrawn from sale for reasons of safety or effectiveness. The determination means that the agency will continue to approve ANDAs that refer to the products as long as they meet