News & Analysis as of

Pharmaceutical Industry The United States Food and Drug Administration Manufacturers

Get by with a Little Help from My Friends (Maybe Not): FDA Reiterates Reliance on Others Doesn’t Ensure Regulatory Compliance

by Arnall Golden Gregory LLP on

Here we go again. The Food and Drug Administration issued a Warning Letter on December 13, 2017, to a Korean pharmaceutical company for non-compliance with current Good Manufacturing Practice requirements. What caught our eye...more

WV Supreme Court Kicks Failure to Warn Case Under Michigan Law

by Steptoe & Johnson PLLC on

The West Virginia Supreme Court of Appeals recently upheld the Mass Litigation Panel’s grant of summary judgment against a class of Plaintiffs alleging birth defects resulting from the use of prescription medicine in...more

Reminder To Update or Certify “No Changes” to Drug Listings Before the End of 2017

by King & Spalding on

Failure To Maintain Listings May Affect Operations and Coverage for Reimbursement – The Federal Food, Drug, and Cosmetic Act (“FDCA”) has long required pharmaceutical manufacturers, repackers, relabelers, and salvagers to...more

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

FDA finalizes 3D printing guidance

by Hogan Lovells on

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”. Please see full Publication below for...more

FDA 2017 Year in Review: Therapeutic Products, Part 2

Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more

FDA Provides Guidance on 3D-Printed Medical Device Products

by Knobbe Martens on

The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more

Third Circuit Splits with the Seventh Over Standing To Sue For Alleged Inefficient Design of Eye Drop Dispenser

In a surprising decision and split with the Seventh Circuit, the Third Circuit recently held that plaintiffs have standing to sue for unfair trade practices under the theory that a manufacturer is obligated to optimize the...more

Guest post – Observations on FDA 3D Printing Guidance

by Reed Smith on

A lot has happened over the past 19 months, some good, some bad, and some just unbelievable. To name a few, and without sounding like a remake of We Didn’t’ Start the Fire, a total solar eclipse, a new human organ was...more

Eleventh Circuit Affirms Preemption of HRT Complaint

by Reed Smith on

Today, December 1, 2017, is the birthday of Gilbert O’Sullivan, who scored a hit back in 1972 with “Alone Again, Naturally,” the saddest song we can think of this side of Albinoni’s Adagio. That is fitting, given our...more

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

by Mintz Levin on

On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Louisiana Adopts Price Reporting Law

by Kelley Drye & Warren LLP on

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines WAC as “the manufacturer’s list price for the pharmaceutical drug or...more

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

by Pepper Hamilton LLP on

Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more

Medical Device Security: FDA Releases Final Guidance On Interoperable Medical Devices

by Reed Smith on

On September 6, 2017, the FDA issued its final guidance on “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices.” This Guidance is intended to address the tension between...more

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Product Liability Update: October 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect

by Arnall Golden Gregory LLP on

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...more

New California Law Limits Drug Manufacturer Co-Pay Cards and Other Discounts in California

by Hogan Lovells on

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

FDA Clarifies Trading Partners Under the DSCSA

by Reed Smith on

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with...more

FDA Issues Guidance on Hurricane Readiness for Medical Devices

The U.S. Food & Drug Administration (FDA) has issued important guidance on how to prepare for hurricanes when dependent on medical devices. FDA stresses that during hurricanes and other emergency situations, medical devices...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

FTC Competition Director Highlights Enforcement Priorities in the Pharmaceutical Industry

Last week Markus Meier, the Acting Director of the Bureau of Competition at the Federal Trade Commission, gave testimony to the House Judiciary Committee concerning “Antitrust Concerns and the FDA Approval Process.” ...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

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