Last month the United States Food and Drug Administration (“FDA”) issued its final guidance (“Guidance”) for the industry on cosmetic product facility registrations and product listings, as required by the Modernization of...more
On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval.
Generally, there are three pathways to importing a prescription drug into the United...more
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development. ...more
FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover...more
Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
10/26/2015
/ Affordable Care Act ,
Department of Health and Human Services (HHS) ,
Discounts ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
Interpretive Rule ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
PHSA ,
Prescription Drugs ,
Public Health Service Act ,
Section 340B
The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more
According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more
The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access...more
The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more
The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA...more
Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more
Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance...more
Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug...more
On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more
The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more
The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the...more
On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more