Will the FDA Kill French Dressing? Are Other Salad Dressings Safe?
The FDA (Food and Drug Administration) has announced its intention to edit the accepted definition of French dressing and the [...]
Biotech and Pharma Puzzled as Headless FDA Changes Course on Drug Reviews
The FDA has made several recent surprising moves when it comes to drug reviews, leaving many biotech companies puzzled and [...]
Upcoming Webinar on COVID-19 Therapeutics and Vaccines
An upcoming webinar will review the data behind treatments for COVID-19, as well as vaccines that have received FDA emergency [...]
The Battle for FDA Commissioner
Advocacy groups are concerned that Acting Commissioner Janet Woodcock will become FDA Commissioner under the Biden administration, stating that she [...]
FDA’s CDER Releases 2021 Guidance Calendar
The FDA (Food and Drug Administration)’s CDER (Center for Drug Evaluation and Research has released its guidance calendar for 2021. [...]
Conversation with Aetion Chief Legal and Executive Officer Provides Insight
Lowell Schiller, J.D., now the Chief Legal and Executive Officer at Aetion, discussed his views on RWE, the FDA, and [...]
Janet Woodcock to be Acting FDA Commissioner
Janet Woodcock is set to be the most powerful person at the FDA in less than a week. The veteran [...]
Read Up On How Regulators Are Using RWE
RWE is playing a growing role in FDA approvals. According to an Aetion analysis, 49 percent of submissions for new drugs [...]
MMIT Partners With Leading Patient Access Hubs
Understanding market access is hard. Tracking shifts in coverage and payer policies for pharmaceutical products is even harder. MMIT partners [...]
ICER Publishes Final Report on Hemophilia A Therapies
Today the Institute for Clinical and Economic Review (ICER) released a report concluding that compared to common current dosing levels [...]
FDA and Industry Set Priorities Through Prescription Drug User Fee Act (PDUFA) Reauthorization
The FDA first began the Prescription Drug User Fee Act (PDUFA) reauthorization process in July. Now the agency has released [...]
FDA Decision Alerts for AYVAKIT™ (avapritinib) and IBRANCE (palbociclib)
Blueprint Medicines Corporation’s AYVAKIT (avapritinib) was approved for adult patients with a specific type of unresectable or metastatic gastrointestinal stromal [...]
FDA Approved NDA for KOSELUGO™ (selumetinib)
Recently the FDA approved AstraZeneca’s KOSELUGO™ (selumetinib) for treatment of pediatric patients two years of age and older with neurofibromatosis [...]
[Podcast] The MM+M Podcast: FDA’s Bakul Patel
Bakul Patel has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010. Tune [...]
[ebook] Version 4.1 of the AMCP Format: Product Dossiers
On December 23, 2019, the Academy of Managed Care Pharmacy (AMCP) released Version 4.1 of the AMCP Format for Formulary [...]
ICER Publishes Evidence Report on Therapies for Hemophilia A
Today the Institute for Clinical and Economic Review (ICER) released a report concluding that compared to common current dosing levels [...]
[Webinar] Bayesian Statistics and FDA Regulatory Acceptability
Bayesian statistics have been used in regulatory submissions to the Food and Drug Administration (FDA) for over 15 years in [...]
[Webinar] Cannabis Research to Reinforce Formulary Coverage Decisions
Cannabis as medicine has generated a tremendous amount of interest in the scientific community. It has also generated a tremendous [...]
ICER to Assess Alzheimer’s Treatment
Today the Institute for Clinical and Economic Review (ICER) announced that it will assess the comparative clinical effectiveness and value [...]
FDA Proposes Rule Change for Off-label Marketing
A proposed rule clarifying when manufacturers would have to update product labeling to reflect unapproved uses of their medicines has [...]
FDA’s Use of Real-World Data (RWD) in the Fight Against COVID-19 Leaves Much to Be Desired
Although the FDA has gone to great lengths to integrate RWD into the fight against COVID-19, the agency still has [...]
ICER finds BioMarin’s Hemophilia Gene Therapy Could Have Warranted a Record Price Tag
Hemophilia is a very expensive disease to treat. Therapies that provide replacement clotting protein are not entirely effective but still [...]
Virtual ISPOR-FDA Summit 2020: Using Patient-Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond
Regulatory decision making for medical devices is increasingly drawing upon Patient-preference information (PPI). Join 18 industry experts on September 29, [...]
BCBSA Exec Aronson Calls for Desperately Needed Validated Outcome Measures for Coverage Decisions
Naomi Aronson, Executive Director for Clinical evaluation at the Blue Cross and Blue Shield Association, didn't mince words in a [...]
FDA Commissioner: COVID-19 Vaccine Must Adhere to Standards for Safety and Efficacy
Stephen Hahn, commissioner of the Food and Drug Administration penned an editorial in the August 5 issue of The Washington [...]